in process quality control & standard operating procedures

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In Process Quality Control & Standard Operating Procedures: 

In Process Quality Control & Standard Operating Procedures Dinesh Kumar Agrawal M.Pharm. (1 st Sem.) Student of Department of Quality Assurances B.N.College of Pharmacy Udaipur E-mail: agrawaldinesh47@gmail.com Cell No: 09314954650

In Process Quality Control: 

In Process Quality Control INTRODUCTION IN-PROCESS CONTROLS- 1.WAREHOUSE OPERATION 2.MANUFACTURING 3.PACKAGING 8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 2 CONTENT

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3 8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR In –process controls cover the entire chain of operations from receipt of material in the warehouse, through its sampling and testing for acceptance, dispensing, manufacturing, packing , final testing and release of the finished product to the warehouse for distribution and or sale INTRODUCTION

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4 8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR AIM- To assure, or increase the assurance of, batch uniformity. There must then be written procedures describing the control and tests or examination to be conducted .the intent is to validate the performance of the process ,or the operation ,that is responsible for .or at least likely to introduce variability in the characteristic

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 5 WAREHOUSE OPERATIONS Visual inspection of in-coming consignment for signs of damage, spoilage, tampering etc. Cross – checking supply details with accompanying documents. Confirmation of proper labeling. External cleaning of containers Checking of performance of the balances used for weighing. Monitoring of temperature and relative humidity in the storage areas .

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 6 Performance of raw materials dispensing booths: air flow patterns pressure across the filters. Sanitation in the warehouse. Confirmation that the materials being dispensed have the right status . Cleanliness of implements used for dispensing the materials and containers in which the materials are dispensed. Equipment log – dispensing cabins &balances used “ Partly used “ material containers and their storage. Spot checks to match card stocks and physical stocks. Accepting materials returned from manufacturing

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 7 IN – PROCESS CONTROLS: MANUFACTURING Display label on the “ Line status “ .operational status of the manufacturing line shall be conspicuously displayed on the entry door. Thus if a product is being processed, the label shall give batch detail; if the line has been cleaned and ready to accept fresh production the label shall be “ Cleaned. Ready for use . ” the label shall also indicate what was the last operation performed /product processed. All equipment also shall carry similar status labels.

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 8 Cleanliness, or otherwise, of a piece of equipment shall be certified by Quality Assurance after performing relevant checks, such as visual/physical examination, environmental testing (e.g. Air quality),wash water testing /analysis etc. there shall be written SOPs for all these activities. Check and certify all ingredients just before use for their control number, and quantity (weight or volume, as the case may be).

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 9 MANUFECTURING OF TABLETS/CAPSULES : Check all the sieves used for their size, cleanliness & damage. Damaged sieves shall not be used. Monitoring and record dry and wet mixing time, as also power input in wet mixing .they should be within specific limits. Deviations, if any, must be rationally explained and authorized . Monitor and record the temperature and time used for drying of wet materials .the values shall be written the specific limits and deviation, if any, shall be explained and authorized. Record the weight of dried granules .yield shall be within the specified limits, and deviation, if any, shall be explained and authorized . Moisture content of /relative humidity over the granules (ready for compression) shall be within the specified limits. Tools (punches & dies) used for tablets compression shall be checked and certified .

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 10 Monitor ,adjust and record at the prescribed frequency ,physical parameter such as individuals weight ,average weight ,tablets thickness ,friability, hardness clarity of inscription ,if any, etc. Monitor and maintain the Disintegrating Time (DT) within the prescribed limits. Temperature & relative humidity of the immediate environment during tablets compression shall be within the prescribed limits . Monitor the yield of the final bulk, it shall be within the specified limits and deviation, if any, shall be explained and authorized. If the tablets are further to be coated monitor adjust where required ,and maintain the relevant parameters such as weight gain ,temp of coating time of drying ,residual moisture ,DT ,etc.

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 11 MANUFECTURING OF LIQUID ORALS : Monitor appropriate variables such as stirrer speed duration of mixing , volume ,pH ,viscosity ,suspension characteristic ,clarity , temperature of the bulk at various stages ,inert gas production if any ,filter assembly and filtration .

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 12 MANUFECTURING OF CREAM/ OINTMENT/ GEL TUBES : Time and temperature used for preparation of various phase shall be recorded. Clarity (in gel preparation), pH, or any such process dependent parameter shall be measured and recorded . Clean the empty tubes by vacuums /pressure. Fill weight of tube and seal tightness shall be checked & recorded during the tube filling operation. Where warranted microbiological quantity of the environment shall be evaluated and recorded .

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 13 MANUFECTURING OF STERILE PRODUCTS : Monitor all manufacturing areas for the microbiological quality of the environment (settle plate, auto-sampler, contact plates etc.). Monitor and record the operation of the steam sterilizers and dry heat sterilizer .visuals indicators to indicate status of materials as far as sterility is concerned may be employed. Test the integrity of the sterile filters before and after their use. Monitor and record the pressure differential between different work areas . Monitor the filled container for filled volume and sealing. Record the quantity and the of rejects at all stages, including the leak testing and final visuals inspection of filled containers .

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 14 PACKAGING OPERATION : All printed packaging components shall be checked against standards approved and in use at the time of packing. Over – printed text, such as Batch No. Price, etc. whether done off-line or on – line shall be verified at scheduled intervals, or earlier, if situation warrants (e.g. when the machine is readjusted for printing). Finished packs shall be regularly evaluated during the packing operation for completeness (e.g. Cup, pack insert etc.).Quantity of contents (e.g. number of tablets, volume of liquid etc.).Seal integrity (e.g. leak testing of tablet strips ).aesthetics ,correct use of printed packaging materials ,any other packaging defects in primary/secondary/tertiary packing. Printed packing components which are spoiled shall be destroyed on-line and quantity recorded. At the end of the packaging operation, all printed packaging materials shall be reconciled . Bulk received and packed shall be reconciled. Discrepancy, if any must be investigated and explained, pending which the product shall not be cleared for distribution

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 15 Standard Operating Procedures CONTENT What is sop Need of sop Benefits of sop Sop-writing styles Format and content of sop Sop process SOPs for various Operations

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WHAT IS AN SOP? 8/30/2011 16 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR

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WHY WRITE SOPs? 8/30/2011 17 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 19 Standard operating procedures are a set of instructions having the force of a directive, covering those features of operations that lend themselves to a definite or standardized procedure without loss of effectiveness SOPs: Detailed written instructions to achieve uniformity of the performance of a specific function.

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 20 An SOP is a set of written instructions that document a routine or repetitive activity. An SOP is a set of instructions or steps someone follows to complete a job safely, with no adverse impact on the environment (and which meets regulatory compliance standards), and in a way that maximizes operational and production requirements

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21 WHY WRITE SOPs? To provide people with all the information necessary to perform a job properly (i.e. a training tool) To ensure that the procedures are performed correctly and consistently To ensure compliance with university and government regulations 8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 22 Benefits of Sop To provide people with all the safety, health, environmental and operational information necessary to perform a job properly. Placing value only on production while ignoring safety, health and environment is costly in the long run. It is better to train employees in all aspects of doing a job than to face accidents, fines and litigation later. To ensure that production operations are performed consistently to maintain quality control of processes and products. Consumers, from individuals to companies, want products of consistent quality and specifications. SOPs specify job steps that help standardize products and therefore quality. .To ensures that processes continue uninterrupted and are completed on a prescribed schedule. By following SOPs, you help ensure against process shut-downs caused by equipment failure or other facility damage. .To ensures that no failures occur in manufacturing and other processes that would harm anyone in the surrounding community. Following health and environmental steps in SOPs ensures against spills and emissions that threaten plant neighbors and create community outrage. .

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 23 To serves as a training document for teaching users about the process for which the SOP was written. Thorough SOPs can be used as the basis for providing standardized training for employees who are new to a particular job and for those who need re-training. .To serves as a checklist for co-workers who observe job performance to reinforce proper performance. The process of actively caring about fellow workers involves one worker coaching another in all aspects of proper job performance. When the proper procedures are outlined in a good SOP, any co-worker can coach another to help improve work skills. .To serves as a checklist for auditors. Auditing job performance is a process similar to observation mentioned in the previous item only it usually involves record keeping. SOPs should serve as a strong basis when detailed audit checklists are developed . .

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 24 To serve as an historical record of the how, why and when of steps in an existing process so there is a factual basis for revising those steps when a process or equipment are changed. As people move from job to job within and between companies, unwritten knowledge and skills disappear from the workplace. Properly maintained written SOPs can chronicle the best knowledge that can serve new workers when older ones move on. .To serve as an explanation of steps in a process so they can be reviewed in accident investigations. Although accidents are unfortunate, view them as opportunities to learn how to improve conditions. A good SOP gives you a basis from which to being investigating accidents To ensures that approved procedures are followed in compliance with company and government regulations. Well-written SOPs help ensure that government regulations are satisfied. They also demonstrate a company's good-faith intention to operate properly. Failure to write and use good SOPs only signals government regulators that your company is not serious about compliance. ..

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 25 Sop – Writing Styles SOPs shall be written in a concise, step by step, easy to read and follow format. The information presented should be unambiguous and not complicated. The active voice and present verb tense should be used. SOP shall be simple and short. Information should be conveyed clearly and explicitly to remove any doubt as to what is required. Flow chart shall be used to illustrate the process being described.

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26 SUGGESTED FORMAT PURPOSE SCOPE RESPONSIBILITY REFERENCES DEFINITIONS PROCEDURE ATTACHMENTS REVISION HISTORY 8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 27 SOP and Decision for format type Sr. No Does SOP involve many decisions? Does SOP consist of more than 10 steps? Best format for writing SOP Examples 1 No No Simple sequential steps SOP for balance calibration 2 No Yes Sequential steps along with Pictorial diagrams Entry / Exit procedure 3 Yes No/Yes Sequential Steps with Flow chart SOP for deviation management

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 28 Company Name and Address: Page No: X of Y Title : SOP No: Revision No: Review Period: Prepared By Reviewed By Approved By Objective Scope Responsibility Procedure Annexure of Sample SOP: Standard Operating Procedure

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 29 YOUR COMPANY VALIDATION STANDARD OPERATING PROCEDURE SOP No. Val. 600.20 Effective date: mm/ dd / yyyy Approved by: No. Section Pages Initials/Date TITLE: Guideline for Area Validation: Clean Area AUTHOR: Name/Title/Department Signature/Date CHECKED BY: Name/Title/Department Signature/Date APPROVED BY: Name/Title/Department Signature/Date REVISIONS:

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 30 SOP No. Val. 600.20 Effective date: mm/ dd / yyyy Approved by: SUBJECT: Guideline for Area Validation: Clean Area PURPOSE To describe the procedure for the area validation of clean area RESPONSIBILITY Concerned departmental managers are responsible for following the pro ­ cedure. The quality assurance manager is responsible for SOP compliance. PROCEDURE 1. Measurements in Unmanned Condition 1.1 Integrity testing of Hepa filters Procedure According to SOP No. Val. 600.30 Requirements According to SOP No. Val. 600.30 Frequency Initial validation: once per HEPA filter unit Revalidation: annually 1.2 Air pressure situation Procedure The overpressure situation should be measured with a pressure gauge over 24 h. Also refer to SOP No. Val. 600.30. Requirements With regard to less clean adjacent areas, the average overpressure should be at least 10 Pa with a maximum deviation of ±2 Pa with regard to the average value . Frequency Initial validation: once for the clean area Revalidation: annually

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 31 Table 1 Square feet Square meter Sampling points 100 9.2 4 200 18.4 8 400 36.8 16 1,000 92.0 40 2,000 184.0 80 4,000 368.0 160 10,000 920.0 400 1.3 Particulate matter in air Procedure The particulate matter in air should be measured with a particle counter Sampling procedure The measurements should be performed at a height of 1.5 m above floor level. The minimum volume of air required per sample can be calculated using the following formula: Volume = 20 particles/class limit (particles/volume) Each sample of air tested at each location shall be of sufficient volume such that at least 20 particles would be detected. The minimum number of sampling points required for measuring the particulate matter in a clean area can be read from Table 1 . This means that not less than two locations should be sampled for a clean area. At each location at least 5 measurements of a volume calculated as described in 1.3 should be performed. Afterwards, the average of the obtained values for each sampling location should be calculated. The average value of the measurements from each sampling location should comply with the requirements. Requirements ð10,000 particles Š 0.5 m m/cft or ð353,000 particles Š 0.5 m m/m 3 ð70 particles Š 5 m m/cft or ð2,470 particles Š 5 m m/m 3 Frequency Initial validation: once Revalidation: annually

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 32 1.4 Temperature Procedure Temperature sensors should be placed on different locations within the clean area. The investigation should be performed over at least 24 hours. Requirements The temperature should be between 20 and 25°C. Frequency Initial validation: once Revalidation: annually 1.5 Relative humidity Procedure The measurements should be performed with a hygrometer. The investi­gation should be done over at least 24 h. Requirements Within the clean area a relative humidity of 40 to 60% should be maintained. Frequency Initial validation: once Revalidation: annually 1.6 Microbiological quality of air Procedure To determine the airborn microbial contamination level, refer to SOP No. Val. 600.30. Requirements Class 100 <3 cfu/m 3 of air Class 10,000 <20 cfu/m 3 of air Class 100,000 <100 cfu/m 3 of air Frequency Initial validation: once Revalidation: refer to SOP No. Val. 600.40

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 33 Maintenance of ampoule filling and sealing machine PURPOSE it is established to provide a procedure for proper filling and sealing of ampoules. SCOPE this is applicable for proper filling and sealing of Ampoule in the liquid Injectables manufacturing section. RESPONSIBILITY Maintenance officer (Mechanical / Electrical) Maintenance Supervisor (Mechanical / Electrical) PROCEDURE The Ampoule Filling Machine with instrument Code No. AFM-87-90-333-334 is handled in the following way. MAINTENANCE

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 34 1 MONITORING OF MACHINE MAINTENANCE: 1.1 Time to time check each and every part of Ampoule Filling machine according to the maintenance schedule. 1.2 Check the following parts carefully. Electric motor Electric Starter V, Belt Bearing and Shafts Bushes Filling Cylinder Filling Nozzles Worm and Gears 1.3 This activity is then documented in the form Machinery & Equipment Maintenance Log 1.4 Check the Ampoule Filling machine condition time to time to find any kind of problem during operation. 1.5 All the monitoring record is filed and kept by the Maintenance Supervisor.

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 35 2 EMERGENCY / BREAKDOWN MONITORING: 2.1 Maintenance Manager receives Maintenance Work Order duly signed by the section in charge of the concerned machinery or equipment. . PRECAUTIONS: Care should be taken while lighting burner to prevent any fire accidents. Always wear protective gloves when handling the dry heat sterilizer. Lubricate the required parts regularly 1.6 Maintenance Work Order is assigned a number according to the receiving in the Maintenance Reference Register 1.7 Maintenance Manager assigns the maintenance work to the concerned personal 1.8 after the completion of work the section in charge signs the completion of Work Order. 1.9 All the record is filed and kept by the Maintenance Supervisor

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 36 STERILE AREA DISINFECTION Objective : To lay down a standard procedure for Sterile Area Disinfection Scope this procedure provides a standard method for routine cleaning of sterile area using Disinfectants to ensure the area is completely free from micro organisms. Responsibility: Senior Chemist - Production Supervisor – Production Housekeeping Procedure: 1. Remove all glass pieces if any, from sterile area after completion of the filling. 2. Clean the filling Machine, SS parts, filling table and floor with distilled water. 3. Use hot distilled water to remove the strain if present. Then use following disinfectants as per the schedule. 4. After cleaning, dry the sterile area for half an hour. 5. The Machine, table, laminar airflow should be wiped with decontaminating solution. 8. Decontaminating solution contains: Liquid phenol 5% w/v Formaldehyde 8% v/v IPA 75% v/v Distilled water QS Spray the hydrogen peroxide solution 20% w/v (Virosil Pharma) after cleaning and wiping. 7. Finally, fumigate by using Formaldehyde and Potassium permanganate.

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AN IMPORTANT POINT An SOP is not a Policy A policy tells you WHAT you will do, An SOP tells you HOW you will do it! 8/30/2011 37 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR

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8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR 38 It shall be noted that the best written SOPs will fail if they are not followed.

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Questions?????? 8/30/2011 39 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR

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THANK YOU E-mail: agarawaldinesh47@gmail.com Cell No: 09314954650 40 8/30/2011 BHUPAL NOBLES COLLEGE OF PHARMACY ,UDAIPUR