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Questions and Answers
What are the four key words that should be kept in mind when carrying out manufacturing operations?
What are the four key words that should be kept in mind when carrying out manufacturing operations?
What does "Identity" refer to in the context of manufacturing operations?
What does "Identity" refer to in the context of manufacturing operations?
Correct identification of product, people, materials, machines, equipment, and locations where the manufacturing operations are carried out.
What is the primary focus of "Strength" in pharmaceutical manufacturing?
What is the primary focus of "Strength" in pharmaceutical manufacturing?
The concentration of the active substance in each unit of the finished pharmaceutical product.
"Safety" only refers to the safety of the person who will consume the product.
"Safety" only refers to the safety of the person who will consume the product.
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What does "Purity" mean in the context of pharmaceutical manufacturing?
What does "Purity" mean in the context of pharmaceutical manufacturing?
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Manufacturing operations should be carried out under the direct supervision of qualified technical staff.
Manufacturing operations should be carried out under the direct supervision of qualified technical staff.
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Operator and worker training is optional in a GMP compliant facility.
Operator and worker training is optional in a GMP compliant facility.
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What is necessary for all materials used in manufacturing processes?
What is necessary for all materials used in manufacturing processes?
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Containers and equipment used in manufacturing should be cleaned to the accepted level, but identification is not necessary.
Containers and equipment used in manufacturing should be cleaned to the accepted level, but identification is not necessary.
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Records should be maintained for cleaning, operations, and maintenance of containers and equipment.
Records should be maintained for cleaning, operations, and maintenance of containers and equipment.
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All activities should be carried out as per approved SOPs, but records are not required.
All activities should be carried out as per approved SOPs, but records are not required.
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What are sanitizing procedures essential for in a manufacturing facility?
What are sanitizing procedures essential for in a manufacturing facility?
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What are the two primary components involved in cleaning?
What are the two primary components involved in cleaning?
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The SOP for facility cleaning should outline the detergent, concentration, frequency, method of cleaning, and persons responsible for cleaning and supervision.
The SOP for facility cleaning should outline the detergent, concentration, frequency, method of cleaning, and persons responsible for cleaning and supervision.
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Disinfection of areas after cleaning should be done using a suitable method, predefined concentration, but without the involvement of dedicated personnel.
Disinfection of areas after cleaning should be done using a suitable method, predefined concentration, but without the involvement of dedicated personnel.
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Records of disinfection activities should be maintained.
Records of disinfection activities should be maintained.
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Records of activities carried out should include the date and time of cleaning, but the names of the individuals who performed and supervised are not required.
Records of activities carried out should include the date and time of cleaning, but the names of the individuals who performed and supervised are not required.
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In pharmaceutical manufacturing what are mix-ups and cross-contamination considered to be?
In pharmaceutical manufacturing what are mix-ups and cross-contamination considered to be?
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What is a mix-up defined as?
What is a mix-up defined as?
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What is contamination defined as?
What is contamination defined as?
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What are the different sources of contamination or mix-ups in pharmaceutical manufacturing?
What are the different sources of contamination or mix-ups in pharmaceutical manufacturing?
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How can improper handling of material lead to contamination?
How can improper handling of material lead to contamination?
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Dusty uncontrolled activities can contribute to contamination.
Dusty uncontrolled activities can contribute to contamination.
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People working in the processing area are not a significant source of contamination.
People working in the processing area are not a significant source of contamination.
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How can people contribute to contamination in a processing area?
How can people contribute to contamination in a processing area?
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People working in the processing area should be trained in proper discipline (keeping movements restricted, using hand gloves, masks, proper uniform, etc.), but medical examination is not required for them.
People working in the processing area should be trained in proper discipline (keeping movements restricted, using hand gloves, masks, proper uniform, etc.), but medical examination is not required for them.
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Anyone with an infectious disease or open wound should be allowed to work in the processing area until they recover.
Anyone with an infectious disease or open wound should be allowed to work in the processing area until they recover.
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People in the processing area should be discouraged from communicating about their illness to their immediate supervisors.
People in the processing area should be discouraged from communicating about their illness to their immediate supervisors.
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Machines and equipment are not another source of contamination.
Machines and equipment are not another source of contamination.
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All equipment should be kept clean and covered when not in use to prevent contamination.
All equipment should be kept clean and covered when not in use to prevent contamination.
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Discharges from equipment and operations should be controlled, but monitoring is not necessary.
Discharges from equipment and operations should be controlled, but monitoring is not necessary.
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Sensitive materials, like β-lactam, steroids, highly toxic or potent drugs, should not be discharged in an uncontrolled manner.
Sensitive materials, like β-lactam, steroids, highly toxic or potent drugs, should not be discharged in an uncontrolled manner.
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Which methods can be used to monitor discharges and prevent uncontrolled releases of contaminants?
Which methods can be used to monitor discharges and prevent uncontrolled releases of contaminants?
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SOPs and records should be kept for cleaning and sanitation of equipment.
SOPs and records should be kept for cleaning and sanitation of equipment.
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Manufacturing areas should be classified according to their expected cleanliness.
Manufacturing areas should be classified according to their expected cleanliness.
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Detailed SOPs should be written for cleaning methods, materials used for cleaning, and cleaning equipment, but validation is not required.
Detailed SOPs should be written for cleaning methods, materials used for cleaning, and cleaning equipment, but validation is not required.
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Records of cleaning done should be maintained.
Records of cleaning done should be maintained.
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To control contamination and mix-ups, exhaust systems with proper air filtration and dust collection should be used.
To control contamination and mix-ups, exhaust systems with proper air filtration and dust collection should be used.
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Collected dust should be disposed of in a controlled manner.
Collected dust should be disposed of in a controlled manner.
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The ideal method for controlling dust is to avoid generation of dust in the first place.
The ideal method for controlling dust is to avoid generation of dust in the first place.
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Separate air handling units should be provided for each workstation activity to prevent contamination.
Separate air handling units should be provided for each workstation activity to prevent contamination.
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Different air pressure (negative or positive) should not be considered when handling different products.
Different air pressure (negative or positive) should not be considered when handling different products.
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Cleaner areas should be maintained at lower air pressure than less clean areas.
Cleaner areas should be maintained at lower air pressure than less clean areas.
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The doors to rooms should open in the direction of the lower air pressure area.
The doors to rooms should open in the direction of the lower air pressure area.
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Production in segregated areas (for products like penicillin, live vaccines, live bacterial preparations) is one way to control contamination.
Production in segregated areas (for products like penicillin, live vaccines, live bacterial preparations) is one way to control contamination.
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Wearing protective clothing is not necessary when handling products with a high risk of contamination.
Wearing protective clothing is not necessary when handling products with a high risk of contamination.
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Ineffective cleaning of equipment is a common source of cross-contamination.
Ineffective cleaning of equipment is a common source of cross-contamination.
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Personnel involved in pharmaceutical processing should be trained in their jobs and the principles of cGMP, but training is not necessary for avoiding cross-contamination or mix-ups.
Personnel involved in pharmaceutical processing should be trained in their jobs and the principles of cGMP, but training is not necessary for avoiding cross-contamination or mix-ups.
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Packaging lines should be segregated to prevent mix-ups.
Packaging lines should be segregated to prevent mix-ups.
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Similar-looking products should be processed in close proximity.
Similar-looking products should be processed in close proximity.
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A SOP and record should be maintained for packaging "line-clearance" before starting packaging of a new batch or product.
A SOP and record should be maintained for packaging "line-clearance" before starting packaging of a new batch or product.
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Line clearance involves the absence of previous batch materials and the presence of the materials required for the next batch.
Line clearance involves the absence of previous batch materials and the presence of the materials required for the next batch.
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Products involved in an unusual event during packaging operations should be investigated, records made, and then immediately packed upon approval.
Products involved in an unusual event during packaging operations should be investigated, records made, and then immediately packed upon approval.
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Any significant or unusual discrepancy observed during reconciliation of bulk product, printed packaging materials, and units produced should be investigated and satisfactorily accounted for before release.
Any significant or unusual discrepancy observed during reconciliation of bulk product, printed packaging materials, and units produced should be investigated and satisfactorily accounted for before release.
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Upon completion of a packaging operation, any unused batch-coded packaging materials should be destroyed, and the destruction should be recorded.
Upon completion of a packaging operation, any unused batch-coded packaging materials should be destroyed, and the destruction should be recorded.
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Standard operating procedures for in-process quality control (IPQC) should be available and followed during manufacturing and packaging activities.
Standard operating procedures for in-process quality control (IPQC) should be available and followed during manufacturing and packaging activities.
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Critical steps in formulation processes should be identified, and parameters to be tested at each stage should be documented.
Critical steps in formulation processes should be identified, and parameters to be tested at each stage should be documented.
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IPQC in packaging activities is not essential, as the focus should be on the manufacturing process.
IPQC in packaging activities is not essential, as the focus should be on the manufacturing process.
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Packaging lines should be continually monitored to ensure the integrity of the finished products.
Packaging lines should be continually monitored to ensure the integrity of the finished products.
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Automated controls and monitors should be checked regularly and validated from time to time in a packaging facility.
Automated controls and monitors should be checked regularly and validated from time to time in a packaging facility.
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Online control of the product during packaging is not necessary.
Online control of the product during packaging is not necessary.
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Tested or inspected samples should be returned back to the packaging line.
Tested or inspected samples should be returned back to the packaging line.
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Releasing of finished products is the last activity in manufacturing and packaging operations, and it is a routine activity that doesn't require extra care.
Releasing of finished products is the last activity in manufacturing and packaging operations, and it is a routine activity that doesn't require extra care.
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Finished products should be placed in quarantine until they're released.
Finished products should be placed in quarantine until they're released.
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Documentation should be reconciled, completed, and sent for a complete audit by quality assurance.
Documentation should be reconciled, completed, and sent for a complete audit by quality assurance.
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When all required parameters are satisfied, including the document audit, QC may recommend release of the product from its quarantine status.
When all required parameters are satisfied, including the document audit, QC may recommend release of the product from its quarantine status.
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The finished product should be released for sale by a designated person from the QA department.
The finished product should be released for sale by a designated person from the QA department.
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What can process deviations be defined as?
What can process deviations be defined as?
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Process deviations should be avoided whenever possible.
Process deviations should be avoided whenever possible.
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Process deviations should be justified, properly authorized, and recorded.
Process deviations should be justified, properly authorized, and recorded.
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If a particular type of deviation occurs frequently, it should be investigated and may be permanently changed.
If a particular type of deviation occurs frequently, it should be investigated and may be permanently changed.
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A pharmaceutical manufacturing process should be completed within a specified time period.
A pharmaceutical manufacturing process should be completed within a specified time period.
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The starting and finishing times of a pharmaceutical process do not need to be recorded.
The starting and finishing times of a pharmaceutical process do not need to be recorded.
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If a process involves multiple stages, it's not necessary to define the maximum time lapse (holding time) between consecutive stages.
If a process involves multiple stages, it's not necessary to define the maximum time lapse (holding time) between consecutive stages.
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Deviations in holding times must be noted, justified, and recorded.
Deviations in holding times must be noted, justified, and recorded.
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Holding a product for an extended period at an intermediate stage poses no potential danger.
Holding a product for an extended period at an intermediate stage poses no potential danger.
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To avoid problems with holding times at intermediate stages, all critical stages in the manufacturing process should be identified, and holding times should be defined based on stability data and GMP related issues.
To avoid problems with holding times at intermediate stages, all critical stages in the manufacturing process should be identified, and holding times should be defined based on stability data and GMP related issues.
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Stability data is standardized across all pharmaceutical products.
Stability data is standardized across all pharmaceutical products.
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Stability data should be readily available to the manufacturing pharmacist or provided in the BPCR for each product.
Stability data should be readily available to the manufacturing pharmacist or provided in the BPCR for each product.
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The pharmaceutical manufacturer's responsibility is to ensure the product's stated potency and therapeutic effectiveness until the end of the shelf life.
The pharmaceutical manufacturer's responsibility is to ensure the product's stated potency and therapeutic effectiveness until the end of the shelf life.
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Shelf life should be determined based on guesswork.
Shelf life should be determined based on guesswork.
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A detailed SOP for conducting drug stability studies is not required.
A detailed SOP for conducting drug stability studies is not required.
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Expiration dates should be based solely on the product's manufacturing date.
Expiration dates should be based solely on the product's manufacturing date.
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Expiration dates should be related to storage conditions stated on labelling.
Expiration dates should be related to storage conditions stated on labelling.
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If a drug product needs to be reconstituted before use, the labelling should only include expiration information for the reconstituted product.
If a drug product needs to be reconstituted before use, the labelling should only include expiration information for the reconstituted product.
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Eye drops are not labelled with information on how long they can be used after opening.
Eye drops are not labelled with information on how long they can be used after opening.
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The expiry date should be printed on the label, but it is not necessary to include the carton or any primary packaging material.
The expiry date should be printed on the label, but it is not necessary to include the carton or any primary packaging material.
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Actual yield and percentage of theoretical yield should be determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of the drug product.
Actual yield and percentage of theoretical yield should be determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of the drug product.
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Yield calculations should be performed by one person and independently verified by a second person.
Yield calculations should be performed by one person and independently verified by a second person.
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Yield calculations only need to be performed at the beginning of the manufacturing process.
Yield calculations only need to be performed at the beginning of the manufacturing process.
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Abnormal deviations in yield should be recorded, investigated to find out reasons, and changes should be implemented to prevent future deviations.
Abnormal deviations in yield should be recorded, investigated to find out reasons, and changes should be implemented to prevent future deviations.
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The main principle of cGMP is "The quality of a product can only be tested in it, not built into it."
The main principle of cGMP is "The quality of a product can only be tested in it, not built into it."
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Quality control or testing can only test certain parameters in the final product, but it cannot assure the quality of the product.
Quality control or testing can only test certain parameters in the final product, but it cannot assure the quality of the product.
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Testing and quality control methods are always completely effective in identifying all potential issues with a batch.
Testing and quality control methods are always completely effective in identifying all potential issues with a batch.
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QA only focuses on testing and does not try to assure that the entire manufacturing process is followed correctly.
QA only focuses on testing and does not try to assure that the entire manufacturing process is followed correctly.
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QA involves performing in-process quality checks and recording them.
QA involves performing in-process quality checks and recording them.
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QA involves collecting samples only at the final stage of the manufacturing process.
QA involves collecting samples only at the final stage of the manufacturing process.
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The reviewer should only look at the quality control documents, not the production record.
The reviewer should only look at the quality control documents, not the production record.
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The reviewer should release the batch for distribution after verifying the entire production record and being satisfied with the quality.
The reviewer should release the batch for distribution after verifying the entire production record and being satisfied with the quality.
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Regulatory literature provides important guidelines for production record review.
Regulatory literature provides important guidelines for production record review.
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Drug production and control records, including those for packaging and labelling, must be reviewed and approved only by the QA department.
Drug production and control records, including those for packaging and labelling, must be reviewed and approved only by the QA department.
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Unexplained discrepancies or failure of a batch should be documented, but a thorough investigation is unnecessary.
Unexplained discrepancies or failure of a batch should be documented, but a thorough investigation is unnecessary.
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The investigation of a failed batch should only focus on the specific batch in question.
The investigation of a failed batch should only focus on the specific batch in question.
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A written record of any investigation should be created and should include the conclusion and follow-up actions.
A written record of any investigation should be created and should include the conclusion and follow-up actions.
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Study Notes
Manufacturing & Packaging Controls
- Good manufacturing practices (GMP) should be followed during all manufacturing operations, including control measures.
- Four key factors are vital: Identity, Strength, Safety, and Purity, ensuring the efficacy of the pharmaceutical product.
Introduction - Identity
- Identity refers to correctly identifying products, personnel, materials, machines, equipment, and locations for manufacturing operations.
Introduction - Strength
- Strength refers to the precise concentration of the active substance in each unit of the finished pharmaceutical product.
Introduction - Safety
- Safety primarily means the safety of consumers of the product.
- Safety also involves the safety of the people who produce the products.
- Manufacturing operations should be safe, alongside the safety of the final product.
Introduction - Purity
- Purity represents freedom from cross-contamination and mix-ups.
Introduction - Achieving these things
- Manufacturing operations must be supervised by qualified technical staff (Industrial pharmacists, chemists, microbiologists).
- Operators and workers need appropriate training, knowledge, skills, and attitudes for their responsibilities.
Introduction-Materials
- All materials must be clearly labeled at each stage, specifying details like name, status, batch numbers, and quantity.
- These materials must be protected throughout the manufacturing process from contamination.
- Stability also needs maintaining.
Introduction-Containers and equipment
- All containers and equipment must be identified and cleaned to the accepted standards.
- Records of cleaning, operations, and maintenance should be maintained.
Sanitation of Manufacturing Premises
- Manufacturing areas should be clean and sanitary.
- Areas for dust, debris, and waste collection in processing areas should be marked.
- Containers for waste should be readily available, made from suitable materials like plastic or stainless steel.
- Collected trash should be removed at regular intervals.
Sanitation of Manufacturing Premises - Cleaning and disinfecting
- Validated cleaning and sanitizing procedures should be used to maintain cleanliness and sanitation in the factory.
- Cleaning involves using detergents and disinfectants.
- SOPs for facility cleaning should specify the detergent, concentration, frequency, method, and responsible individuals.
Sanitation of Manufacturing Premises - Records
- Records of cleaning activities, including date, time, and personnel involved should be maintained.
Mix-Ups and Cross Contamination - Definitions
- Mix-ups occur when undesired materials enter desired materials (e.g., tablets of different products, products in wrong cartons).
- Contamination occurs with materials not wanted, even if unseen (e.g., fine dust).
Mix-Ups and Cross Contamination - Sources
- Sources include materials, people, machines, and processing areas.
- Improper handling, broken containers, uncontrolled activities can cause contamination.
Mix-Ups and Cross Contamination - People
- People working in processing areas are a significant source of contamination.
- Such people must adhere to protocols (trained, restricted movements, using protective gear, medical checkups) to prevent contamination.
Mix-Ups and Cross Contamination - Additional
- Individuals with infectious diseases or open wounds should not work in processing areas.
- Staff should immediately inform supervisors of illnesses that could affect product quality, particularly concerning aseptic areas.
Mix-Ups and Cross Contamination - Machines and equipment
- Machines, equipment, and related activities are considerable contamination factors.
- All equipment must be clean and covered when not in use.
- Discharges (dust, smoke, etc.) must be controlled.
Mix-Ups and Cross Contamination- Further measures
- Monitoring contamination by using systems like dust collection or water/solvent scrubbing.
- Maintaining records for cleaning and sanitation.
Mix-Ups and Cross Contamination - further measures
- Manufacturing areas should be categorized by cleanliness levels (aseptic filling, non-sterile).
- Thorough and validated cleaning and sanitizing SOPs must be implemented.
- Cleaning records must be kept.
Mix-Ups and Cross Contamination - Controls
- Exhaust systems, air filtration, closed material handling, and separate air handling units help control contamination.
- Different air pressure zones (positive/negative) in different rooms should be implemented based on product types.
- Segregated areas for high-risk products (e.g., penicillin, live vaccines).
Mix-Ups and Cross Contamination - additional measures
- Personnel must wear protective clothing in high-risk areas.
- Cleaning and decontamination procedures (proven effectiveness) to prevent cross-contamination from equipment.
- Staff training in GMP principles to avoid mix-ups and cross-contamination.
Mix-Ups and Cross Contamination - Packaging
- Packaging lines in central packaging areas should be separated (at least 1.2-1.5 m).
- Similar products should be prevented from being processed or packed consecutively.
- Maintaining SOPs and records for checking packaging line clearance before each batch.
Mix-Ups and Cross Contamination - Area Clearance/Machine Clearance
- Documents to record and verify area/machine clearance for further processing, and including re-cleaning.
Packaging Operations
- Packaging should follow precautions (similar to manufacturing).
- Prevent cross-contamination.
- All packaging equipment and lines should be cleaned between batches.
Packaging Operations - Line Clearance
- SOP with records for packaging line clearance maintaining absence of previous batch material.
Packaging Operations- Labelling and packing
- Proper and timely labeling and final packing are essential to prevent mix-ups.
- Clearly plan and segregate overprinting activities.
- Quality and durable labeling is important and should be visible.
- Follow labeling guidelines, including time frames.
- Use of a suitable drying ink (or other appropriate method) will reduce mix-up risks.
Packaging Operations -Additional Control
- Use of empty packet detection systems (for tabs/caps).
- Online packaging checks for defects in appearance, completeness, correct materials, correct labels, and weights.
Packaging Operations - Further aspects
- Records for unusual events in packaging (investigations, vigilance).
- Thorough reconciliation of packaging materials and quantities before product release.
- Unused materials (that are discarded) must have proper disposal records.
Production of Intermediate and Bulk Products
- Raw materials are processed into packaging-ready bulk goods.
- Identity, strength, safety, and purity checks are vital.
- Before processing, materials must be verified for identity and quantity.
Production of Intermediate and Bulk Products - Procedures
- Areas and equipment must be clean.
- Pipelines, equipment, and other related tools should be checked and cleaned to eliminate any contamination risks.
- Environmental factors (temp, humidity, etc.) must meet the processing requirements.
Production of Intermediate and Bulk Products - Process Measurements
- Yield of materials throughout processing should be checked and compared with theoretical predictions.
- All measuring, weighing, and control equipment must be calibrated.
- Records of calibrations are maintained.
Production of Intermediate and Bulk Products - Further Considerations
- Repairs and maintenance activities should not jeopardize product quality.
- All specified IPQC checks must be performed at pre-determined points.
- Specialized areas and equipment are needed for medicinal products.
IPQC in Manufacturing - General Guidelines
- Having detailed SOPs is essential for in-process quality control.
- Critically examining steps and establishing specifications is necessary.
- Data from various manufacturing tests (e.g., assay, moisture, bulk density) is needed.
IPQC in Manufacturing - Further guidelines
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Check physical parameters for compression tablets (weight, hardness, friability).
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Collect data on fill weights, volumes, or the pH of solutions before finishing.
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Essential to monitor environmental conditions (temperature, humidity, etc.).
IPQC in Packaging
- Continuously monitor packaging lines for packaging integrity
IPQC in Packaging - Procedures and Automated Control Measures
- Use of tabulated checklists and competent personnel to verify and sign the checklists.
- Regular inspection and validation of automated controls and monitors.
IPQC in Packaging - Online Product Control
- Online monitoring of general appearance (of products), physical defects, weights, volumes, quantity, components, and materials used.
IPQC in Packaging -Further aspects
- Recording sample collection for testing procedures.
- Maintaining appropriate records of environmental conditions during processing.
Release of Finished Products
- Finished products are released for commerce after processing
Release of Finished Products - Conditions
- Placement of products into quarantine (with documentation completed) to prevent unexpected or improper product removal.
- An audit by quality assurance (to check and reconcile documentation) is essential before release.
- The QA department authorizes product release.
Process Deviations
- Deviations from predefined procedures (process deviations) are a possibility.
- Such variations should be avoided whenever possible.
- Exceptionally, if deviations are mandatory, they must be justified and recorded properly.
Process Deviations - Further Measures
- Frequent deviations require thorough investigation and potential modifications to the procedures using change control.
Time Limitations on Production
- Pharmaceutical production processes have specific time limits.
- Minimizing production time periods/lapses between stages.
- Proper and defined time limits/holds for intermediate stages (holding times).
- Documentation of deviations and any potential dangers caused by holding times.
Time Limitations on Production - Further Considerations
- Critical stages, the importance of holding times, and stability of each product must be clarified and documented accordingly.
- Detailed information must be available to the pharmacist or in the BPCR.
Expiration Dating - Principles (General aspects)
- Pharmaceutical product potency and effectiveness must be maintained till the expiration date.
- The expiration date depends on stability studies and the required product conditions.
- Detailed SOPs for stability studies.
Expiration Dating
- Data from stability studies must be used to determine the expiration date.
- Any storage conditions must be included in the labeling.
Expiration Dating - Additional guidelines
- Products that need reconstitution at dispensing time: should have expiration information for both the reconstituted and un-constituted forms.
- Packaging for products that must be used after opening.
Calculation of Yield
- Actual yield must be calculated and recorded. Theoretical vs. actual yields help determine efficiencies.
- The appropriate stages should be identified to calculate theoretical yield.
Calculation of Yield - Further Aspects
- Any deviation from expected yields must be investigated and the reasons recorded.
- SOPs should be established for theoretical and actual measurements.
Production Record Review - Fundamental Aspects
- The principle of cGMP implies that product quality is built-in, not just tested at the end.
- Quality control tests have limitations (like sterility tests).
Production Record Review (Quality Assurance aspects)
- QA verifies the entire production process, ensuring it followed the prescribed procedures.
- QA includes steps such as carrying out in-process quality checks, collecting samples throughout the process, and verifying all production-related documents.
Production Record Review - Quality Control Measures
- Review records related to the batch(e.g., quality records) alongside production-related documents.
- QA personnel should approve all production records before release.
Production Record Review - Further aspects
- Any unexplainable discrepancy about production batches must be thoroughly investigated.
- The investigation must include other related products (batches).
- Records for the investigation must be maintained and should include conclusions.
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Description
This quiz covers the essential principles of Good Manufacturing Practices (GMP) in the pharmaceutical industry. Key concepts such as Identity, Strength, Safety, and Purity are explored, highlighting their importance in ensuring product efficacy and consumer safety. Dive into the critical control measures required for successful manufacturing operations.
