GMP SOP الجودة الدوائية PDF

GMP CHAPTER 2 STANDARD OPERATING PROCEDURE SOP Lecturer: Dr. Iman Hamdan Faculty of Pharmacy Al Zaytoonah University 1  Contents WHAT IS STANDARD OPERATING PROCEDURE? OBJECTIVES WHY IT IS ESSE...

GMP CHAPTER 2 STANDARD OPERATING PROCEDURE SOP Lecturer: Dr. Iman Hamdan Faculty of Pharmacy Al Zaytoonah University 1  Contents WHAT IS STANDARD OPERATING PROCEDURE? OBJECTIVES WHY IT IS ESSENTIAL? BENEFITS TYPES OF SOP SOP WRITING STYLE POINTS TO BE KEPT IN MIND WHILE WRITING SOP INSIDE THE SOP STEPS OF SOP COMMON EQUIPMENTS USED FOR LIQUID AND SEMI SOLID PEPARATION GENERAL SOPS 2 ❖Set of written instructions that is followed routinely or repetitively. ❖Created culture where Quality objectives are Transparent, well understood, and Undoubtedly these goals can be achieved by certain sets of Procedures called as “Standard Operating Procedures”. ❖Back bone of Pharmaceutical Industries. ❖SOPs describe both technical and fundamental programmatic operational elements of an organization that would be managed under a work plan or a Quality Assurance (QA) Project Plan. 3 1. If it isn’t written down, it didn’t happen. 2. If it isn’t written down properly, it didn’t happen either. 3. Don’t forget rules 1 and 2.  3rd layer in documentation 1st GLP and 2nd Company policies Q.A. Documentation GMP Q.C. ❑To describe the responsibilities of the coordinating center for managing and monitoring the participating sites. ❑To provide guidelines for accurate and timely data collection, resolution of data clarifications (queries). ❑ To detail the regularly recurring work processes that are to be conducted or followed within an organization. ❑To facilitate consistent conformance to technical and quality system requirements and to support data quality. 6  Continued…. ❑To maintain their quality control and quality assurance processes ❑To ensure compliance with governmental regulations. ❑To serve as a training document for teaching users about the process for which the SOP was written. 7  Why it is Essential ? ❖An fundamental part of successful quality system. ❖Plant’s effectiveness and efficacy. ❖Regulatory requirement. ❖To ensure that production operations are performed consistently to maintain quality control of processes and products. ❖To ensure that processes continue uninterrupted and are completed on a prescribed schedule. 8 ❖Provides information to perform job properly. ❖To provide people with all safety, health, environmental and operational information necessary to perform job properly. ❖Also provides, consistency (very imp. In any of the field) ❖Gives information in order to achieve pre-determined specification and quality end-result. ❖Minimizes variation and promotes quality. Steps can be reviewed in accident investigations. ❖Serves as a training document for users. 9  Continued…. ❖SOPs assist to ensure that GMP is followed and achieved at all times. ❖SOPs assist the pharmacy personnel to know who does what, and when, thus avoiding confusion, and function overlapping. This also takes care of accountability and responsibility. ❖SOPs help to assure the quality and consistency of the service, and thus minimize harm to the patient. ❖SOPs are useful tools for training new members of staff. ❖SOPs give clarity to the pharmacy personnel, to follow steps/procedures, systematically, and uniformly. 10  Safety To Deal & With Fundamental Precaution Complaints Analytical method Types Prep. Of Reagents of SOP Instruments/ Q.A. Methodic equipment & apparatus 11 ❖SOPs shall be written in a concise, step by step, easy to read and follow format. ❖Information should not be complicated. The active voice and present verb tense should be used. ❖Should be simple and short. ❖Routine procedures that are short and require few decisions can be written using simple steps format. ❖Long procedures consisting of more than 10 steps, with few decisions should be written along with graphical format or hierarchical steps. 12  Continued…. ❖Procedures that require many decisions should be written along with flow chart. ❖Requirement for document identification and control, accountability and traceability responsibility must be included with every SOP; this can be achieved by providing consistent format. 13 DO ✓ Write in the presence tense. Don’t write in the past, conditional or future tense unless you have good reason to do so. ✓ Avoid ambiguity. ✓ Be concise. ✓ Keep the words short and get to point. ✓ Move from one step to another step in logical manner. ✓ Highlight exception. Use a symbol to flag that this is an exception and how to handle it. 14  Continued…. ✓ Highlight warning. Again warn users that caution must be used in this scenario. Warning must stand out; use a larger font or a warning icon. ✓ Reduce the word count where possible without altering the meaning of the text. 15  DO NOT DO  Introduce acronyms without explaining what it means.  Don’t use the word “may”, “if possible” as it implies that the user can do something under conditions. Instead be positive and tell them what to do. 16 Company name and pagination. The company name and pagination (e.g. page 4 of 7) must appear on every page. Title The title should be descriptive. The title should use directive language to declare what is being done to what. Identification Procedures must be easily identified by giving unique number and version number. This identification number of the SOP supports accountability of the document throughout the facility and over time as it changes. 17  Continued…. Review and approval All SOPs shall have space for signature of initiator (the person who has written the SOP) Reviewer (The persons who has reviewed the SOP) Approver (Quality Assurance Head of the organization). Purpose The purpose or objective of the procedure should restate and expand well written title. Expand or qualify the directive language used in the title (e.g. to describe the operation procedure of compression machine) 18 Scope The scope should provide limits to the use of procedure. The scope shall be written in such a way that it answers following questions…. ▪ Are there certain samples that are appropriate to test by this method? ▪ Do these operations apply only to certain equipment or certain departments? ▪ Is there a limit to the capacity, volume, or throughput of the procedure? ▪ State to what areas this procedure does apply and does not apply? Responsibility Who is responsible for performing the work described? Who is responsible for implementing the procedure? Procedure Describe the procedure in a step by step, chronological manner. Use active verbs and direct statements 19  1. Sop Preparation 2. SOP Review and 5. Management of Approval SOP SOP PROCESS 3. Frequency of Revisions and 4. Implementing Reviews SOP 20  SOP Preparation ❑ The organization should have a procedure in place for determining what procedures or processes need to be documented. ❑ SOPs should be written by an individual who performs the tasks routinely or someone who is directly responsible for the performance of the task. 21 Environmental Performs the job Equipment personnel manufacturers Who will/can write SOP? Performs maintenance Safety personnel Technical initiation on equipment 22  SOP Review and Approval SOPs should be reviewed by one or more individuals with appropriate training and experience with the process especially helpful if draft SOPs are actually tested by individuals other than the original writer before the SOPs are finalized. 23  Frequency of Revisions and Reviews SOPs need to remain current to be useful. Therefore, whenever procedures are changed, SOPs should be updated and re-approved. If desired, modify only the pertinent section of an SOP and indicate the change date/revision number for that section in the Table of Contents and the document control notation. SOPs should be also systematically reviewed on a periodic basis, e.g. every 1-2 years, to ensure that the policies and procedures remain current and appropriate, or to determine whether the SOPs are even needed. 24  Implementing SOP ❑ The most important step for implementing the SOP is in working area, train or retrain the user. Everyone should follow the procedure exactly with each and every step in detail, it is very important to train the user otherwise individual may interpret meaning in different ways. ❑ While training the user trainer should share the reason WHY, SOP must performed correctly. People are much more to follow when they understand importance of procedure. ❑ Trainer should explain and demonstrate how each step in the SOP will be performed and should assure them this will increase Quality of product by providing safety and accuracy which will ultimately increase the confidence of the user. 25  Management of SOP Organization shall have SOP on Preparation, approval, revision and control of standard Operating Procedure for better control and management of SOPs. Generally, administrative aspects of the SOP system such as distribution and filing are well managed. On the other hand, overall system management, frequently characterized by the lack of a system owner, is generally poor. If a system owner exists at all, his or her responsibilities are limited. 26 Ideally a system owner Eliminates obsolete SOPs. (Which is not needed) Ensures that SOPs meet their quality requirements and are user friendly. Manages SOP change controls. Distributes SOPs. Ensures that SOPs are current. Ensures that new or changed SOPs are valid only after training has occurred and provides training about the SOP system. Measures system performance and periodically reports results to management. Continuously improves the system. Name of facility_____________________________________ page.......... of.... SOP Number ________ Title _________________________________________________ Revision number ________ Written by ______________________________ Edited by __________________________ Authorization signature ________________________ Department _______ Date___________ Effective date __________________________________Replaces ____________________ Purpose: WHY: Why is this procedure written. Why is it being performed. Scope WHEN: Indicate when this procedure needs to be performed. WHERE: Indicate where this procedure applies. Responsibility WHO: Who performs the procedure, who is responsible to see it is performed correctly. Materials and equipment WHAT: What is needed to perform the test. The list should be completely specific. 28 29 Semisolid Vanishing Cosmetics cream Gel & Jellies Cream Paste Tooth paste Cold cream Plaster Nail lacquers Suppository Lipstick Face wash 30  Liquid dosage form Oral Parenteral Monophasic Biphasic Simple Solutions Suspension Emulsion Drops (Solid in (Liquid in Syrups Liquid) Liquid) Elixirs 31 Jacketed Kettle Mixing & storage Steam heated Filter press tanks/Vessels Gas heated Electrically heated Pilfer proof cap sealing machine Liquid/Jar/Tube Common filling equipment Equipment As per GMP Deionizer Planetary mixer Colloid Clarity tester Triple roller mill/Emulsifier mill/Ointment mill 32 Pilfer Proof Cap Sealing Machine 33  SOP for Cleaning of Vessels Fill the tank with hot tap water (50°-60°C). Pass the steam through jacket to raise the temperature. Drain this water. Fill the tank with water-detergent mixture (0.1% Teepol solution). Heat and drain this water. Use plain hot water to rinse the tank at least twice. Clean the exterior of the tank with warm plain water & interior with freshly collected distilled water. Pass the steam through the jacket to make it dry. Clean lid & place it over tank. Label appropriately. 34 Continued…. ❑ Label should include following details: ✓ Name of equipment :- ✓ Date 7 time of Cleaning :- ✓ Name of operator :- ✓ Name & batch no of previous product :- ✓ Name & batch no of next product :- ✓ Checked by :- Title :- Cleaning of manufacturing Ref. No :- Vessel. Version :- Name of Mfg. :- I D No :- Department :- Page No :- Effective Date :- Review Date :- Prepared By Approved By Authorized By 35  SOP for Mixing of Aqueous & Oily phase Check the closure of all the outlet valves and “cleaned” label. Open the inlet valve & Transfer the aq. And oil phase from their respective mixing tanks. Start heating and agitation at predetermined rate for specified time period. Locate mixing process intermittently through sight glass. Stop agitation and heating after the specific time gap. Allow the product to cool at specified temperature and homogenize it. Transfer the finished product to filling unit. Record the details of processing. 36  SOP for Packaging & Labeling Assure the cleanliness & dryness of the container. Open the lid. Place the containers below the nozzle of syringe on a conveyer belt. Adjust the volume to be filled in each container. Switch on the filling machine. Check the filling process intermittently. Switch off when process is complete. Replace the lid. Stick the label. Keep the containers in final container. Record the details of packaging and labeling. 37  SOP for Liquid mixing Ensure that tank is closed & has ‘cleaned’ status label where “use before date” has not lapsed. Ensure that the bottom valve of the tank is closed. Open the top lid of the mixing tank/storage tank provided for loading the material. Transfer the purified water & required material as per BMR of the particular of the particular batch. Close the lid of the mixing tank/storage tank. Run the stirrer for the time duration mention in the respective manufacturing record, speed adjustment can be done. After completion of mixing, switch off the stirrer. Affix the status label. 38  SOP for Filtration (Filter Press) Check the equipment clean and ready for use. 25 liter of syrup to be filtered is taken in a tank and 1 kg filter aid is suspended in it. This slurry is pumped into the chamber and air is displaced from the top. Stop outlet when syrup starts coming out. Remove the filtrated syrup from the bottom outlet of the chamber and recirculate until the out coming filtrate is clear. Connect the main compound to the filter press pump and open the valve. Filter the outcoming into storage tank, which is previously cleaned. Label the tank suitable. 39  SOP for Rotary Bottle Washing Machine Remove glass piece if present. Fill the respective tank with fresh DM water. Ensure that stainless steel tray is properly cleaned before loading the bottles. Inspect the broken bottles and reject is found before sending for washing. Choose the correct size of holder and fix on the stainless steel platform. Turn the pump switch and adjust the pump pressure of each pump with the help of control valves. Place the bottles in inverted position on empty nozzles which are to be washed, when washing is completed unload the washed bottles in aluminium clean perforated tray in inverted position. Dry the washed bottles in oven at 120°C for 1 hour. 40 Conclusion ✓ SOPs serve as a fundamental means of communication for all levels of the organization. Not only do they involve employees departmentally, but they also allow management and employees to gain a cross- functional view of the organization. This approach encourages employees to think about how process change may affect other functional areas. ✓ A good system forces Employee to think through processes and examine how Procedure might affect product, personnel, production, and equipment. ✓ It shall be noted that the Best written SOPs will fail if they are not followed. 42  References 1. http://aboutgdp.blogspot.in/2010/05/standard-operating-procedures- sops.html 2. http://www.pharmainfo.net/reviews/standard-operating-procedures- sop-back-bone-pharmaceutical-industries 3. http://pharmatips.doyouknow.in/Articles/Pharmaceutical- Equipment.aspx 4. http://en.wikipedia.org/wiki/Standard_operating_procedure 5. http://pharmaceuticalsops.blogspot.in/2010/09/ 43  AIM HIGH THANK YOU 45