Change Control Process Charge-in of Components Quiz

Sterilizing product components and processing equipment

Establishing documented evidence of a specific process

QA department

To qualify the environment

Using clean room garments

To ensure batches conform to standards

A systematic review of compliance by supervisors and managers

Accidental deviation

Both A and B

Audit by SAHPRA and FDA

To ensure compliance with written procedures

Effective compliance operation

Control of microbiological contamination

To ensure the dosage forms have the identity, strength, quality, and purity they are represented to possess

QA and responsible person

To define how things are to be done and provide a basis for the training of new or relocated personnel

Record and justify the deviation

To document the execution of production and process control functions

Preventing changes that conflict with regulatory requirements

To accommodate batch analytical variations

To ensure batches fall within an acceptable range of actual yield

Recording a major equipment by a distinctive ID number or code

When the active ingredient shows assay results that are not exactly 100%

To allow for investigation of identified problems

Testing in-process materials for identity, strength, quality, and purity

Biological activity

To assure the quality of the drug product

To prevent their use in manufacturing or processing operations

To ensure batch uniformity and integrity

Validating all aseptic and sterilization processes

The two types of deviations from the defined procedure are planned and unplanned.

In the event of a planned deviation, appropriate documentation and approvals, including QA, should be obtained prior to execution.

In the investigation of a deviation, an investigation is typically performed, the potential impact on involved batches is determined, and corrective and preventative action (CAPA) is generated.

The purpose of the Change Control Process is to evaluate change potential impact and, where necessary, provide appropriate evaluation and/or actions.

The purpose of reprocessing in process validation is to ensure that the process remains in control and produces acceptable results.

The purpose of the quarantine system for rejected in-process materials is to prevent their use in further processing or distribution.

Treatments of product components and processing equipment to remove particulate matter, sterilize, and depyrogenate

Control of microbial contamination and clean room garments

Establishing and following procedures, review and approval of the QA department

Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics

To validate environmental qualifications such as air quality, people, time limitations, and product filtration

To ensure that reprocessed batches conform to all established standards, specifications, and characteristics

The measures and activities included in the production system are: control of the manufacture of in-process materials and the final drug products, establishing, following, and documenting the performance of approved manufacturing procedures.

The typical pharmaceutical manufacturing operations include: written procedures and deviations, charge-in of components, calculation of yield, equipment identification, sampling and testing of in-process materials and drug products, time limitations on production, control of microbiological contamination, and reprocessing.

The purpose of written procedures and deviations in production and process control is to assure that the dosage forms have the identity, strength, quality, and purity they are represented to possess.

The appropriate organizational units review and approve the written procedures and deviations, and the quality assurance (QA) unit confirms the review by a responsible person and further reviews the document for possible adverse impacts on quality and safety.

The purpose of Bath Manufacturing Records (BMRs) is to provide documentation at the time of performance and to ensure that written production and process control procedures are followed in the execution of the various production and process control functions.

Proper equipment identification during production requires appropriate equipment labeling and identification tags to ensure accurate tracking and documentation of equipment usage.

The purpose of the Change Control Process is to facilitate a review of any proposed change and monitor the impact of the change in order to prevent changes that could adversely affect product quality or conflict with regulatory requirements.

The new container should be identified with the following information: (1) component name or item code, (2) receiving or control number, (3) weight or measure in new container, (4) batch for which component was dispensed, including its product name, strength, and lot number.

For manual operation, each container of component dispensed to manufacturing shall be examined by a second person to assure that: (1) The component was released by the quality control unit. (2) The weight or measure is correct as stated in the batch production records. (3) The containers are properly identified.

For automated equipment operation, it requires only one person to verify these operations and assure that the component was released by the quality control unit, the weight or measure is correct as stated in the batch production records, and the containers are properly identified.

For manual operation, it requires one person to add the component and a second person to verify.

For automated equipment operation, it requires one person to verify the addition of the component.

The key points in sampling and testing of in-process materials and drug products include establishing and following written procedures to assure batch uniformity and integrity of drug products, monitoring the output and validating the performance of manufacturing processes responsible for variability, and testing for characteristics such as tablet or capsule weight variation, disintegration time, adequacy of mixing, dissolution time and rate, clarity and pH of solutions, and bioburden/microbial testing.

The requirements for establishing valid in-process specifications for characteristics of in-process materials include consistency with drug product final specifications, derivation from previous acceptable process averages and process variability estimates, and application of suitable statistical procedures.

The requirements for testing in-process materials for identity, strength, quality, and purity include approval or rejection by QA during the production process, testing at commencement or completion of significant phases or after long periods of storage, and identification and control of rejected materials under a quarantine system.

Time limitations on production are important for sensitive processes that require established time limits for completion to ensure the quality of the drug product. Examples include bulk injections vulnerable to microbial attack, materials subject to oxidation, and tablet granulations or bulk solids that absorb or release moisture on storage.

The key points in controlling microbial contamination in drug products include the establishment and following of appropriate written procedures to prevent objectionable microorganisms in nonsterile products and to prevent microbiological contamination in products purporting to be sterile. Procedures should include validation of aseptic and sterilization processes.

The characteristics that may be included in the control procedures for in-process materials and drug products include tablet or capsule weight variation, disintegration time, adequacy of mixing, dissolution time and rate, clarity, completeness, or pH of solutions, and bioburden/microbial testing.