Manufacturing Documentation : Manufacturing Documentation Preapred by: Kamal Kardani M.Pharm (QA) Semester II Guided by: Dr. V. K. Parmar Mrs. Bhavna Patel PG Department of Pharmaceutical Sciences Sardar Patel University Contents : Introduction Raw Material Record Labels And Printed Packaging Material Records Master Formula Record Batch Production Record Quality Control Record Calibration Record Distribution Record Batch Packaging Record Record Keeping Reference Contents Introduction : Introduction Definition for Documents: The ISO defines records as “ information created, received and maintained as evidence and information by an organization or person, in pursuance of legal obligation or in the transaction of business” The International Council on Archives (ICA) committee on electronic records defines a record as “a recorded information procedure or received in the initiation, conduct or completion of an institutional or individual activity and that comprises content, context and structure sufficient to provide evidence of activity Introduction : Introduction D = Design, development, deviations, dossiers & Drug Master Files for regulated markets, distribution records O = Operational procedures/techniques/methods , Out of specifications (OOS) , Out of trend (OOT) C = Cleaning, calibration, controls, complaints, containers and closures, contamination and change control U = User requirement specifications, utilities like water systems, HVAC,AHU etc. M = Man, materials, machines, methods, maintenance, manufacturing operations and controls, monitoring, master formula, manuals (quality, safety and environment), medical records E = Engineering control and practices , Environment control, Equipment qualification documents N = Non-routine activities, New products and substances T = Technology transfer, training, testing ,Trend analysis .Technical dossiers S = SOPs, safety practices, sanitation, storage, self-inspection, standardisation, supplier qualification, specifications and standard test procedures and site master file. Introduction : Introduction Advantages: Maintenance of management Information about equipment A record can be either a tangible object or digital information Give information about premises, product, personnel etc. Manufacturing Records: Specification and standards Raw Material Records Labels and printed packaging material records Master Formula Records Batch Production Records Quality Control Records Calibration & Validation Records Distribution Records Batch Packaging Records Manufacturing Records Specification and Standards: This type of records gives information about the specification and comparision with the standards Specification of raw material Specification of packaging material Specification of finished product Format: Specification and Standards Specification and Standards Raw Material Record: The Schedule U To The Drug And Cosmetic Rules Requires Following Particulars To Be Shown In The Raw Material Records : Date Of Receipt Invoice No Name And Address Of Manufacturer/ Supplier Batch No Quantity Received Pack Size Date Of Manufacture Date Of Expiry Date Of Analysis And Release/Rejection By Quality Control Raw Material Record Raw Material Record: Raw Material Record Analytical Report No Quantity Issued Date Of Issue Name And Batch No Of The Product For Manufacture Of Which Issued Proper Disposal Of Stocks Format: Raw material record Labels and Printed Packaging Material Records : The Indian GMPs requires the records of labels and printed packaging material indicating receipt examination relating to testing and whether accepted or rejected to be maintained. Format: Labels and Printed Packaging Material Records Labels and Printed Packaging Material Records Master Formula Record: The Indian GMPs require a maintenance of master formula record for each product Who prepare it? Who review it? MFR describes following : Name and strength of the product along with dosage form The name and weight/measure of active ingredients per dosage unit or per unit weight /measure of the product and total weight/measure of any dosage unit A complete list of all ingredients to be used in the manufacture of the product indicating any special quality characteristics . Master F ormula Record Master Formula Record: An accurate statement of weight/measure of each ingredient require as per formula of dosage form and the weight/measure actually to be used A statement of theoretical yield including permissible limits beyond which investigation is required. A description of container, closures and packaging material to be used A description of all vessels, equipment to be used Processing and packaging procedures In-process Control to be taken during manufacture and storage of semi-finished and finished product . Formula: Master Formula Record Master Formula Record Batch Production Records: BPR are required to be maintained for each batch of a drug manufactured. Particular which are essentially to be recorded in manufacturing records have been described under schedule U to the drugs and Cosmetics Rules. Batch production record is a documentation that shows that significant manufacturing processes and in-process controls were accomplished in accordance with master formulation record for that product. BPR includes: Dates Identity of individual major equipment Specific identification of each raw material used Weight and measure of raw material used in manufacturing process including initial of person who weighted or measured each material and of the person who counter-checked the weight or measure. Batch Production Records Batch Production Records: Record of actual amount of each batch of raw material if material of more than one batch is used Amount of any recovered product residue or reprocessed material used, if any In-process control and laboratory results A statement of actual yield and theoretical yield at appropriate stages of manufacture Description of container and closures Any sampling performed during processing Identification of persons performing and directly supervising critical steps of manufacturing Details of any signed authorisation for any deviation from master formula record Any investigation of specific failure or discrepancies Actual quantities of labelling and printed packaging material used Format: Batch Production Record Batch Production Records Quality Control Record: Definition: it is that part of GMP, which is concerned with sampling, specification and testing organization, documentation and release procedures which ensure that the necessary and relevant tests are in fact carried out and that materials are not released for role and supply until their quality has been adjudged satisfactory. Aim: QC lab works for the establishment of scientifically sound, detailed instructions in print for: Checking of raw materials, work in progress and final market packages. Test conducted for analysis of raw materials, goods in process, finished products. Standards for rejection/release. Label preparation and expiry date. Control and testing of returned good. Quality Control Record Quality Control Record: Particulars that should be essentially mentioned in the QC records have been laid down under schedule U of D&C act. The QC records must shows The date of performance of test Identification of material Name of supplier(of raw material) Date of receipt Batch number Quantity received(raw material) Date and quantity of sample taken Specification employed for testing All data secured in the course of each of test including all graphs, charts, print cuts etc. Quality Control Record Quality Control Record: Calculation performed in connection with testing including units of measures conversion factors and equivalence factors. A statement of the result of tests and how the results compare with established standard of identity, purity and strength. The initials are signature of person who performs the test. The initial or signature of second person showing that records have been received for accuracy, completeness and compliance with standards. Certificate number issued Description of QC unit accepting or rejecting the materials. Format: Quality C ontrol Record Quality Control Record Calibration Records: Calibration:- The act of checking or adjusting (by comparison with a standard) the accuracy of a measuring instrument. Why? To confirm suitability of the equipment and proper operation of the apparatus. When? Before using new test equipment After relocation or major maintenance Calibration Records Calibration Records: The procedure must include the following details: Name of instrument Date of calibration reference standard used Other reagents or tool used Deviation Name & sign of person who calibrated Format: calibration record Calibration Records Distribution Record: It is a written data related to distribution of drug products from the manufacturer to the distributors. These records should be maintained in such a way that complete up to date and progressively recorded data of all batches of drug products are easily available. Every distributor is also obliged to maintain a complete and accurate record of further distribution Why?? An inventory card may be maintained to find out stock position quickly. A distribution register may be maintained for detailed information about distribution of each batch of drug product. Format: Distribution R ecord Distribution Record Batch Packaging Records: Batch Packaging Record should be kept for each batch or part batch processed. It should be based on the relevant parts of the Packaging Instructions and the method of preparation of such Records should be designed to avoid transcription errors. The record should carry the batch number and the quantity of bulk product to be packed, as well as the batch number and the planned quantity of finished product that will be obtained. Before any packaging operation begins, there should be recorded checks that the equipment and work station are clear of previous products, documents or materials not required for the planned packaging operations, and that equipment is clean and suitable for use. Batch Packaging Records Batch Packaging Record: The name of the product; The date(s) and times of the packaging operations; The name of the responsible person carrying out the packaging operation; The initials of the operators of the different significant steps; Records of checks for identity and conformity with the packaging instructions including the results of in-process controls; Details of the packaging operations carried out, including references to equipment and the packaging lines used; Whenever possible, samples of printed packaging materials used, including specimens of the batch coding, expiry dating and any additional overprinting; Notes on any special problems or unusual events including details, with signed authorisation for any deviation from the Manufacturing Formula and Processing Instructions The quantities and reference number or identification of all printed packaging materials and bulk product issued, used, destroyed or returned to stock and the quantities of obtained product, in order to provide for an adequate reconciliation. Batch Packaging Record Retention of Record: Record should be kept in such a way that activities concerning the production and QC of API are traceable. Record should be retained for at least one year after the expiry of the finished product or for a specified period if there is no expiry date. Life cycle of record have three stages: Stage 1 : A ctive U se- the record is currently in use and/or is referred to frequently Stage 2 : S emi A ctive u se- T he record is not in current use but still referred to on occasion Records in stage 1 & 2 are retained and stored for as long as they are useful to the organization, whether that be for six months or ten years. Very few records, if any are actually in semi active use after ten years. Records no longer in use are in the final stage of life cycle that is stage 3. Stage 3 : Disposition - The record is no longer use. It is rarely or never needed for reference. It is no longer needed for legal or financial purposes. Most record in stage 3 are destroyed or discarded Retention of Record PowerPoint Presentation: Any Queries???????? ? PowerPoint Presentation: Thanking all of You….