logging in or signing up Quality audit nishit_patel5 Download Post to : URL : Related Presentations : Let's Connect Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Copy embed code: Embed: Flash iPad Dynamic Copy Does not support media & animations Automatically changes to Flash or non-Flash embed WordPress Embed Customize Embed URL: Copy Thumbnail: Copy The presentation is successfully added In Your Favorites. Views: 410 Category: Science & Tech.. License: All Rights Reserved Like it (0) Dislike it (0) Added: December 08, 2011 This Presentation is Public Favorites: 0 Presentation Description No description available. Comments Posting comment... Premium member Presentation Transcript A Seminar On Responsibility, sampling Plan, routine Control On, Reagent & Standard Testing Procedure: A Seminar On Responsibility, sampling Plan, routine Control On, Reagent & Standard Testing Procedure KARAN TRIVEDI 1 Presented By: Guided By: Karan Trivedi Nishit Patel Roll No: 15 Assistant Professor 1 st sem. M.Pharm Q.A Department Of Pharmaceutical chemistry Dharmaj Degree Pharmacy College, DharmajContent:: Content: KARAN TRIVEDI 2 Responsibility Sampling Plan Routine Control on Instrument & Reagent Standard Test ProcedurePowerPoint Presentation: RESPONSIBILITY Study Director’s Responsibilities 1. The Study Director is the single point of study control and has the responsibility for the overall conduct of the study and for its final report. 2. These responsibilities should include, but not be limited to, the following functions. 3 KARAN TRIVEDIPowerPoint Presentation: The Study Director should: a) Approve the study plan and any amendments to the study plan by dated signature. b) Ensure that the Quality Assurance personnel have a copy of the study plan and any amendments in a timely manner and communicate effectively with the Quality Assurance personnel as required during the conduct of the study. c) Ensure that study plans and amendments and Standard Operating Procedures are available to study personnel. 4 KARAN TRIVEDIPowerPoint Presentation: d) Ensure that the study plan and the final report for a multi-site study identify and define the role of any Principal Investigator(s) and any test facilities and test sites involved in the conduct of the study. e) Ensure that the procedures specified in the study plan are followed, and assess and document the impact of any deviations from the study plan on the quality and integrity of the study, and take appropriate corrective action if necessary. 5 KARAN TRIVEDIPowerPoint Presentation: f) Ensure that all raw data generated are fully documented and recorded. g) Ensure that computerised systems used in the study have been validated. h) Sign and date the final report to indicate acceptance of responsibility for the validity of the data and to indicate the extent to which the study complies with these Principles of Good Laboratory Practice. i) Ensure that after completion (including termination) of the study, the study plan,the final report, raw data and supporting material are archived. 6 KARAN TRIVEDIPowerPoint Presentation: Principle Investigator’s responsibilities: The Principal Investigator will ensure that the delegated phases of the study are conducted in accordance with the applicable Principles of Good Laboratory Practice. 7 KARAN TRIVEDIPowerPoint Presentation: Study personnel’s responsibilities 1. All personnel involved in the conduct of the study must be knowledgeable in those parts of the Principles of Good Laboratory Practice which are applicable to their involvement in the study. 2. Study personnel will have access to the study plan and appropriate Standard Operating Procedures applicable to their involvement in the study. It is their responsibility to comply with the instructions given in these documents. Any deviation from these instructions should be documented and communicated directly to the Study Director, and/or if appropriate, the Principal Investigator(s). 8 KARAN TRIVEDIPowerPoint Presentation: 3. All study personnel are responsible for recording raw data promptly and accurately and in compliance with these Principles of Good Laboratory Practice, and are responsible for the quality of their data . 4. Study personnel should exercise health precautions to minimise risk to themselves and to ensure the integrity of the study. They should communicate to the appropriate person any relevant known health or medical condition in order that they can be excluded from operations that may affect the study. 9 KARAN TRIVEDIPowerPoint Presentation: SAMPLING DEFINATION: 1) Sampling “Sampling is the procedure for collecting a sample, means a small part or quantity intended to show what the whole (or entire lot) is like” Or “The process of evaluating a portion of the product in a lot for the purpose of accepting or rejecting the entire lot as either conforming or not conforming to a quality specification” 2) Sampling plans “Sampling plans is the one which is to be established which involves decision as to when, where and how the sample should be taken and whether the process of sampling should be a one-off or it should be repeated and how often” 10 KARAN TRIVEDIPowerPoint Presentation: It is of two types: Attributor plans : A random sample is taken from the lot and each unit is classified as acceptable or defective. The number of is then compared with the allowable number stated in the plan and a decision is made to accept or reject the lot . Variable plans : A sample is taken and a measurement of a specified quality characteristic is made on each unit. These measurements are then summarized in simple statistics, and the observe value is compared with and allowable value defined in the plan. A decision is then made to accept or reject the lot. 11 KARAN TRIVEDIPowerPoint Presentation: The “n plan” In this plan, samples can be withdrawn from any part of the container. It is based on the formula n=√N where, N=number of sampling units in the consignment 12 KARAN TRIVEDIPowerPoint Presentation: The “p plan” This plan is used when the material is uniformed and has been received from a well-known and time tested supplier. It may be used when the main aim is to check identity. This plan is based on the formula P=0.4√N Where N=number of sampling units. 13 KARAN TRIVEDIPowerPoint Presentation: The “r plan” This plan may be used when the material is either suspected to the non uniform or has been received from a supplier who is not well-known This plan is based on formula r=1.5√N where N=number of sampling unit 14 KARAN TRIVEDIPowerPoint Presentation: 3) S ampling scheme (sampling schedule): When there is a regular requirement for analysis the sampling plan is referred to as a sampling scheme or a sampling schedule . 4) Sampling programme: This is commonly used to describe a combination of procedures where several related sampling schemes are combined. 15 KARAN TRIVEDIPowerPoint Presentation: INTRODUCTION: In quality control activity “sampling” is one of the major activity Reason for the importance of sampling activity lies in the fact that one cannot always non destructively analyze the material and hence a small population of the material is collected as representative samples or the material and tested for its quality. Hence if sample is really not representing then the test performed on and conclusions drawn from this will not be correctly representing the quality of the product 16 KARAN TRIVEDIPowerPoint Presentation: Hence the entire sampling activities get lot of attention of all the regulatory authorities. The various points covered in this includes: 1 ) Sampling area 2) Sampling procedures 3) Reference samples 4) Sampling of starting and packing materials 5) Sampling of I.P.Q.C. material 6) Sampling of bulk finished and packed material 7) Different guidelines for sampling 17 KARAN TRIVEDIPowerPoint Presentation: 1) SAMPLING AREAS There should be separate area in the warehouse, for active pharmaceutical ingredients, excipients, and materials. However if sampling is performed in any other area, it should be conducted in such a way as to prevent contamination, cross contamination and mix-ups. Separate areas may be provided for sampling of liquids, hazardous, poisonous and explosive material where required. A separate area may be provided for sampling of primary packaging materials; however secondary and tertiary packaging material may be sampled on the location of storage. In process, bulk finished and packed material may be sampled on the location in the processing or packaging departments with due respect to avoid mix-ups. 18 KARAN TRIVEDIPowerPoint Presentation: 2) SAMPLING PROCEDURES Sampling procedures is considered as one of the critical procedures. Following points should be considered while carrying out sampling procedures: Sampling should be representative of the batches of materials from which they are taken in accordance with the approved written procedures. The number of containers to be sampled, and the amount of material to be taken from each container shall be based upon appropriate criteria such as: -statistical criteria for component variability, - degree of precision desired, -the past quality history of the supplier Samplings should be carried out so as to avoid contamination or other adverse effects on quality. The containers that have been sampled should be marked accordingly and carefully resealed after sampling. 19 KARAN TRIVEDIPowerPoint Presentation: Care should be taken during sampling to guard against contamination or mix-ups of or by the material being sampled. All sampling equipment that comes in contact with the material should be clean. Some particularly hazardous potent material may require special precautions. Sampling equipment should be cleaned and if necessary, sterilized before and after each use and stored separately from laboratory equipment. 20 KARAN TRIVEDIPowerPoint Presentation: Following procedure should be followed for sampling : The containers of component selected shall be cleaned where necessary by appropriate means. The containers shall be opened and sampled and resealed in a manner designed to prevent contamination of their contents and contamination of other components, drug product container or closures. Sterile equipment and aseptic sampling techniques shall be used when necessary. 21 KARAN TRIVEDIPowerPoint Presentation: If it is necessary to sample a component from the top, middle and bottom of its container, such samples sub division shall not be composite for testing. Sample containers shall be identified so that following information can be determined. The name of the material sampled The batch or/lot number The number of container from, which sample has been taken The signature of the person who has taken the sample The date of the sampling. Containers from, which samples have been taken shall be marked to show that samples have been removed from them 22 KARAN TRIVEDIPowerPoint Presentation: 3) REFERENCE SAMPLES Reference sample means a representative sample of substance used in the manufacture of the pharmaceutical product as also the sample of the finished pharmaceutical product. Reference samples are also called ‘Retention Samples’ There are slight different in the requirement of keeping reference/retention samples in different regulatory guidelines. Following are some of the major guiding principles. 23 KARAN TRIVEDIPowerPoint Presentation: WHO guidelines say that: Retention samples from each batch of finished product be kept for at least 1yr after the expiry date. Finished product should usually be kept in their final packaging and stored under the recommended condition. If exceptionally larger packages are produced, smaller samples might be stored in appropriate condition, of same of construction. Samples of active starting material should be retained for at least 1yr beyond the expiry of the corresponding finished product . Other starting material (other than solvent, gases, and water) should be retained for a minimum of two years if their stability allows. Retention samples of material and product should be of a size sufficient to permit at least two full examinations. 24 KARAN TRIVEDIPowerPoint Presentation: TGA guidelines say that: Ref. samples of material and product should be of sized sufficient to permit at least one full re-examination. U.S.F.D.A gives following view: These guidelines are quite elaborate as compared to the other international regulatory guidelines presently available as; An appropriately identified reserve sample i.e., representative of which lot in each shipment of each active ingredient shall be retained. The reserve sample consists of at least twice the quantity necessary for all tests required to determine whether the active ingredient meets its established specification. The retention time for all products other than radioactive substances and an active ingredient in an O.T.C drug product, shall be one year after the expiration date of the last lot of the drug product containing the active ingredient. 25 KARAN TRIVEDIPowerPoint Presentation: For active ingredient in a radioactive drug product, except for non-radioactive reagent kit, sample shall be retained for: (a)Three months after expiration of the date of last lot of the drug product containing the active ingredient if the expiration dating period of the drug product is 30 days or less. (b)Six months after expiration of the date of last lot of the drug product containing the active ingredient if the expiration dating period of the drug product is more than 30 days. For an active ingredient in an O.T.C drug product that is exempted from bearing an expiration date, the reserve sample shall be retained for 3 yr after distribution of the lot of the drug product containing the active ingredient. For finished product the reserve sample shall be retained for one year after expiration date of the drug product. 26 KARAN TRIVEDIPowerPoint Presentation: 4. Sampling of starting and packaging material: Principle: Sampling is an important operation in which only a small fraction of a batch is taken. Valid conclusion on the whole cannot be based on tests which have been carried out on non representative sample. Correct sampling is thus an essential part of system of Q.A. Starting material: The identity of a complete batch of starting material can normally be ensured if individually sampled are taken from all the containers and an identity test performed on each sample. If it is permissible to sample only a portion of the container where a validated procedure has been established to ensure that no single container of starting material will be incorrectly identified on its label. 27 KARAN TRIVEDIPowerPoint Presentation: The validation should take account of at least the following aspects. Nature and status of the manufacturer and of the supplier and their understanding of GMP requirements of the pharmaceutical industries. The Q.A. system of the manufacturer of the starting material. Manufacturing condition under which the starting material is produced and controlled. The nature of the starting material and the medicinal products in which it will be used. Under such arrangements it is possible that a validated procedure exempting identity testing of each incoming container of starting material could be accepted for: Starting materials coming from a single product manufacturer or plant. Starting material coming directly from a manufacturer or in the manufacturer’s sealed container where there is a history of reliability and regular audits of the manufacturer’s Q.A. system are conducted by the purchaser. 28 KARAN TRIVEDIPowerPoint Presentation: The improbable that a procedure could be satisfactorily validated for Starting materials supplied by intermediates such as brokers where the source of manufacture is unknown. Starting materials for use in parenteral products. The quality of a batch of starting materials may be assessed by taking and testing a representative sample. The samples taken for identity testing could be used for this purpose. The no. of samples taken for the preparation of representative sample should be determined statistically and specified in a sampling plan. The no. of individual samples which may be blended to form a composite sample should also be defined, taking into account the nature of the material, knowledge of the supplier and the homogeneity of the composite sample. 29 KARAN TRIVEDIPowerPoint Presentation: Packaging material: Sampling plan for packaging materials should take account of at least the followings. The quantity received The quality required The nature of materials The production methods The knowledge of Q.A. system of the packaging material manufacturer based on audit. The no. of samples taken should be determined statistically and specified in sampling plan. 30 KARAN TRIVEDIPowerPoint Presentation: 5. Sampling of IPQC material: The USFDA gives specific guidance on IPQC sampling and testing. Following are the points discussed in these guidelines. Purpose: To assure batch uniformity and integrity of the drug product. SOP should be prepared for sampling of IPQC materials and their testing. The results obtained from such tests should be used for monitoring the progress of manufacturing process. Selection of parameters: Those parameters which are responsible for causing variability in the characteristics of the in process material and the drug product are selected. 31 KARAN TRIVEDIPowerPoint Presentation: For tablets and capsules: Weight variation Disintegration time Dissolution time and rate Adequacy of mixing etc. b. liquid preparation: Clarity Completeness of solutions pH filled volumes c . semisolids : viscosity d. packaging: leak tests Overprinting details etc. 32 KARAN TRIVEDIPowerPoint Presentation: Specification: What specification should be meet at each criteria stage of manufacturing should be identified and limits defined, so that sample collected, can be tested and results compared against the specification so that the manufacturing process can be monitored in desired direction . 6. Sampling of finished bulk and packed finished products: A detailed SOP should be written to spell out the stages at which such samples be taken and what tests should be carried out at each such stages of sampling. Logic may be used to avoid repeated unwarranted testing to reduce the testing load without causing adverse effects on the quality of products being produced. 33 KARAN TRIVEDIPowerPoint Presentation: 7. Different guidelines for sampling: (A) WHO GUIDELINE: Sampling: Samples should be taken in such a manner that they are representative of the material from which they are taken, in accordance with approved written sampling procedures. These procedures includes: -The method of sampling -The equipment to be used. -The amount of sample to be taken. -Instruction for any required sub-division of the sample. -The type and condition of sample container to be used. -Any special precaution to be observed, especially in regard to sampling of sterile or noxious material. -Cleaning and storage of sampling equipment. 34 KARAN TRIVEDIPowerPoint Presentation: Any sampling by production personnel should only be done in accordance with these approved procedures. Each sample container should bear a label indicating its content, with the batch or lot no. reference and the date of sampling. The sampler should initial on the label and there should be an indication from which container sample was taken. It should also be possible to identify the bulk containers from which samples have been drawn and which containers have been sampled. Care should be taken to avoid contamination or deterioration whenever a material or product is sampled. Sampled containers should be resealed in such a way so as to prevent damage to, or contamination of, or by, the contents. 35 KARAN TRIVEDIPowerPoint Presentation: Retention samples from each batch of finished products should be kept in their final packaging and stored under the recommended conditions. Samples of starting materials (other than solvents, gases and water) should be retained until at least the expiry date of the batch in which they are used. Reference samples of materials and products should be of a size sufficient to permit at least one full reexamination. (B) USFDA guidelines: Each lot of components, drug product containers, and closures shall be withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for the use by Q.C. unit. 36 KARAN TRIVEDIPowerPoint Presentation: Representative samples of each lot shall be collected for testing or examination. The no. of containers to be sampled, and the amount of material to be taken from each container, shall be based upon appropriate criteria such as statistical criteria for components variability degree of precision desired the past quality history of a supplier the quality needed for the analysis and reserved where required by Samples shall be collected in accordance with the following procedure. The containers of components selected shall be cleaned where necessary by appropriate means. The containers shall be opened, sample, and resealed in a manner design to prevent contamination of their contents and contaminations of other components, drug product containers, or closures. Sterile equipments an aseptic sampling technique shall be used when necessary. If it is necessary to sample a component from the top, middle, and bottom of its container, such samples sub division shall not be composited for testing. 37 KARAN TRIVEDIPowerPoint Presentation: Sample containers shall be identified so that the following information can be determined. Name of the material sample The lot number The containers from which the samples was taken The date on which the sample was taken The name of the person who collected the sample Containers from which samples have been taken shall be marked to show that samples have been removed from them. 38 KARAN TRIVEDIPowerPoint Presentation: SOP on sampling should cover minimum following points . TRAINED PERSONNEL Sampling should be classified as critical operational activity and only those persons (workers and supervisors) should be allowed to do sampling who are trained in all aspects of sampling and certified as trained person by Q.A. authority. These names may preferably be notified in sampling area. The training should cover minimum following points. Sampling plans i.e. which sampling plan should be used for which material. Written sampling procedures must be explained to all the sampling workers and their supervisors, including various precautions to be taken before, during and after the sampling activities Techniques and equipments used in sampling Issue related to risk of cross contamination 39 KARAN TRIVEDIPowerPoint Presentation: Precautions to be taken with regard to unstable (E.g. moisture, light or heat sensitive product) and or sterile substance. The importance of considering the visual appearance of material, containers and labels. The importance of recording any unexpected or unusual circumstances. Regular retraining and refresher training sessions may be conducted an evaluation made and records of such activities should be maintained. 40 KARAN TRIVEDIPowerPoint Presentation: Environment: The sampling environment is of utmost important. Normally special separate sampling booths should be designed and use for active, inactive, critical active substances like beta- lectum products, steroids, toxic or poisonous substances, sterile products etc. The following points should also need to be considered. Temperature Humidity Working of laminar flow units Direct exposure of sunlight 41 KARAN TRIVEDIPowerPoint Presentation: Equipments : All equipments use for sampling should be cleaned, dry and where required sterilized. Such reprocess equipments should be stored in well protected manner E.g. in clean plastic wrapper and then store in a clean SS container till required for use. A provision for washing and drying may be provided adjacent to sampling area. Equipments and area cleaning procedures must be validated and record of such validations should be maintained. 42 KARAN TRIVEDIPowerPoint Presentation: Contamination control: All precautions should be taken to avoid cross contamination during sampling operations. These should cover at least following points. Area cleaning and certifying before and after sampling Handling only one product at a time Proper way of opening and closing containers to be sampled Using clean hand glows for each materials being sampled 43 KARAN TRIVEDIPowerPoint Presentation: Proper dress code followed during sampling, E.g. use of nose and face mask, head gear, feet cover, glows. Always use clean, dried, sanitized equipment and whenever required sterilized for sampling . Collection and transfer of used equipment for cleaning in a closed and protected manner . Validated methods should be used for cleaning of weighting equipment whenever used 44 KARAN TRIVEDIPowerPoint Presentation: Method used: Different types of sampling plans may be used depending upon the availability of validation data on the subject, E.g. 100% sampling- when not much data is available Reduced sampling- when validated data is available about manufacturers Sterile product sampling- current practice is to sample in the aseptic areas of production or if possible in Q.C. laboratory. 45 KARAN TRIVEDIPowerPoint Presentation: But the latest thinking is to construct a separate aseptic area for sampling purpose only, adjacent to the warehousing facility. These should be a class 100/10000 area with minimum for vestibules(passage) for entry and exit of personnel, suitably pressurized, with a provision of dynamic pass box of suitable size of transfer of material to and from sampling area. The environmental conditions of such rooms must be monitored, controlled and records maintained. 46 KARAN TRIVEDIPowerPoint Presentation: Reference and retained sample: All samples collected should also cover the samples to be retained till at least one year after the expiry of the product. The SOP should also be mentioned at least following points. Quantity of sample to be retained (may be at least two full analysis equivalent) Container type to be used for retention Labeling requirement on such retained containers Storage and retrieval to be followed along with proper records Environmental conditions needed for storage of such samples Detailed procedures of the reference samples of finished products to be collected and stored must be written. They should clearly mention sample for stability studies if they are kept from a particular batch. 47 KARAN TRIVEDIPowerPoint Presentation: Labeling: Each sample containers should bear a following labeled indicating. Name of the sampled materials Batch or lot number or the material No. of container from which the sample is taken Initial signature of the person who has taken the sample The date of sampling The containers from which the sample is taken should be marked to indicate that this container was opened for sampling purpose. 48 KARAN TRIVEDIPowerPoint Presentation: Sealing of sampled containers: Very clear instructions should be provided about how to reseal the open container. E.g. remove all air from the plastic bags before closing the bags for sealing. The correct way of sealing should also be described to avoid possibilities of cross contaminations 49 KARAN TRIVEDIPowerPoint Presentation: Records: Following records should be maintained Identity of material sampled E.g. name, batch and number etc. Chronological record of sampling i.e. time and date of sampling Record of environmental conditions E.g. temperature, humidity during sampling A name of workers and supervisors Comments if any, of the sampler and/or supervisor 50 KARAN TRIVEDIPowerPoint Presentation: Types of samples: There are several ways one can describe a sample. It can described in terms of the physical state e.g. gas, liquid, solid. Another way of describing samples is in terms of the sampling plan used. Using these description ,there 4 types of samples. Representative Selective Random Composite 51 KARAN TRIVEDIPowerPoint Presentation: A) Representative sample This is a sample that is typical of the parent material for the characteristic under the inspection. To obtain an adequate representative sample ,we must take account of the state of the parent material we have to examine. These are of 4 types Homogenous Heterogeneous Static Dynamic 52 KARAN TRIVEDIPowerPoint Presentation: B) Selective sample Chose the samples from bulk have maximum or minimum contamination possibility. This may be called directed/focusing sampling. You may have chosen any case where contamination is suspected E.g. Rodent contamination of flour by hair or urine ,toxic gases in factory environmental where the total level may be acceptable but a localized sample may contain lethal contamination. 53 KARAN TRIVEDIPowerPoint Presentation: C) Random sample: It will eliminate question of bias, because in this sample is selected so that a portion of the material has an equal chance of being chosen. There are 3 types Simple random sampling Stratified random sampling Systemic sampling 54 KARAN TRIVEDIPowerPoint Presentation: D) Composite sample : Composite sampling is a way of reducing cost of analyzing large number of samples. A composite sample consist of two or more portion of material selected so as to represented the material being investigated. The component of the composite sample are taken in proportion to the amount of the material they represent. 55 KARAN TRIVEDIPowerPoint Presentation: RECORDS: B.M.R Batch packing record Record for receipt of material: Name of the material on container Date of receipt Supplier’s name and manufacturer’s name. Total quantity with number of containers received Batch number assigned after receipt 56 KARAN TRIVEDIPowerPoint Presentation: Records for sampling Person authorized for sampling Sampling equipment and methods to be used Quantities to be sampled Precautions to be taken while sampling to avoid deterioration Other records include: Records for release and rejection of material Records of distribution of each batch of product Chronological recording of the use of major equipment and areas where products are exposed. 57 KARAN TRIVEDIPowerPoint Presentation: ACCEPTANCE QUALITY LEVEL (AQL): AQL is related to the quality required in the product. It is not description of sampling plan. AQL is the maximum percentage nonconformity that, for the purpose of this sampling inspection ,can be considered satisfactory as a process average. AQL has particular significance in the design and use of acceptance sampling plans. % nonconformity can be calculated by , %nonconformity=(No. of nonconformity in units/no of units examined)X 100 Nonconformities per 100 units = (no. of defect in units examined/no of units examined)x 100 58 KARAN TRIVEDIPowerPoint Presentation: E.g. if 200 cans are examined and it is found that 3 have low protein,2 have low carbohydrate and protein, and 1 is low in fat, protein and carbohydrate, this leaves 194 satisfactory cans. % nonconformity =(6X 100)/200 =3 i.e. 3% of the batch does not confirm with the requirements. Where AQL is greater than 100,there must be more than one nonconformities per item examined. 59 KARAN TRIVEDIPowerPoint Presentation: INSPECTION LEVEL Inspection level defines a relationship between batch size and sample size i.e. no. of units examined The inspection level will be prescribed by the responsible authority. For general use , three inspection levels 1,2,3 are given and for small batches, special levels S1,S2.S3 and S4 . 60 KARAN TRIVEDIPowerPoint Presentation: TYPES OF INSPECTION Normal, tightened or reduced inspection may be used. Tightened inspection is introduced when 2 out 5 batches are rejected. Tightened inspection means more samples need to be inspected. If the quality is consistently better than the AQL than sampling plan can be modified so that sample size can be reduced to 2/5 th of total required for normal inspection. 61 KARAN TRIVEDIRoutine control on Instrument: Routine control on Instrument 62 Machine Log Book Instrument List & I.D. Label Calibration Report Area Monitoring S.O.P Record of Instrument KARAN TRIVEDITemperature Record: Temperature Record 63 Sr No. Date Temperature Time Q.A. sign. 1 1/10 23 10:00 am N.S.Patel 2 2/10 23 10:00 am N.S.Patel 3 3/10 24 10:00 am N.S.Patel 4 4/10 24 10:00 am N.S.Patel 5 5/10 25 10:00 am N.S.Patel 6 6/10 25 10:00 am N.S.Patel 7 7/10 25 10:00 am N.S.Patel KARAN TRIVEDIHumidity Record: Humidity Record 64 Sr No. Date Humidity Time Q.A. sign. 1 1/10 43 % 10:30 am N.S.Patel 2 2/10 43 % 10:30 am N.S.Patel 3 3/10 44 % 10:30 am N.S.Patel 4 4/10 44 % 10:30 am N.S.Patel 5 5/10 45 % 10:30 am N.S.Patel 6 6/10 45 % 10:30 am N.S.Patel 7 7/10 45 % 10:30 am N.S.Patel KARAN TRIVEDICleaning Record : Cleaning Record 65 Sr No. Date Cleaned by Time Q.A. sign. 1 1/10 Rakesh 10:45 am N.S.Patel 2 2/10 Vijay 10:45 am N.S.Patel 3 3/10 Manoj 10:45am N.S.Patel 4 4/10 Raju 10:45am N.S.Patel 5 5/10 Rajesh 10:45am N.S.Patel 6 6/10 Mahesh 10:45am N.S.Patel 7 7/10 Ravi 10:45am N.S.Patel KARAN TRIVEDIRoutine Control On Reagent: Routine Control On Reagent 66 Working Standard Record of Volumetric Reagent Preparation of Different Reagent KARAN TRIVEDIStandard Test Procedure: Standard Test Procedure 67 KARAN TRIVEDIReferences:: References: KARAN TRIVEDI 68 Potdar M.A, cGMP (Current Good Manufacturing Practice), PharmaMed Press, First Edition Sharma P.P, GLP(Good Laboratory Practice) Good Laboratory Practice OECD PRINCIPLES AND GUIDANCE FOR COMPLIANCE MONITORINGHAPPY DIWALI…… : HAPPY DIWALI…… KARAN TRIVEDI 69PowerPoint Presentation: KARAN TRIVEDI 70 Thank You You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.