Documentation in GMP (Good Manufacturing Practices)

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All the doccuments required in GMP


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A Seminar On Documentation:

A Seminar On Documentation Prepared By- Riddham Patel, M.Pharm Sem -I, QA Department, HNSIPER. Guided By- Poonam Thumar , Faculty , QA Department, HNSIPER. 1 HNSIPER


Contents Why Documentation is necessary in pharma industry??? Aim of documentation Inclusions Of Documentation !!! Records Labels Specifications And Testing Procedures Master Formulae Packaging Instructions Batch Production And Control Records (BPCR) / Batch Manufacturing Records Batch Packaging Records (BPR) Site Master File Standard Operating Procedures (SOPs) References 2 HNSIPER

Why Documentation is necessary in pharmaceutical industry???:

Why Documentation is necessary in pharmaceutical industry??? Documentation is a key area for companies in the pharmaceutical industry. The United States Food and Drug Administration (FDA )- the governmental agency, that is responsible for overseeing the industry, requires extensive documentation for every manufacturing and packaging lot of all pharmaceutical products. The FDA mandates documentation for the sake of accountability and traceability . This practice is to ensure safe and effective pharmaceutical products. 3 HNSIPER

Aim of documentation:

Aim of documentation To define the specification for all materials. To define methods of manufacture and control. To ensure that all personnel connected with manufacturer and control know what to do and when to do. To ensure that the personnel authorized to release a batch for sale or reject it, have all the information that is necessary to take decision. To provide information during investigation, if a batch is suspected to have defect(s). To make available data needed for validation , review and statistical analysis. 4 HNSIPER

Inclusions Of Documentation !!!:

Inclusions Of Documentation !!! Revised schedule M has the following elements which are related to documentation:----- Records Labels Specifications And Testing Procedures Master Formulae Packaging Instructions Batch Production and Control records (BPCR) / Batch Manufacturing Records Batch Packaging Records (BPR) Standard Operating Procedures (SOPs) 5 HNSIPER


Records Records to be maintained 6 HNSIPER

Records to be maintained:

Records to be maintained Receipt and issue records of raw materials and containers Log book of assigning batch number Analysis record (Generally by Q.C. department) Finished product distribution records Major critical equipment cleaning, maintenance, calibration, validation records House keeping, maintenance, cleaning and sanitization records Personnel matters including qualification, training etcetera Environmental monitoring Complaints Recalls Returns 7 HNSIPER


Labels Introduction Label of finished product Label of reference standard 8 HNSIPER


Introduction In pharma industry, Labels are used for identification and/or status of container, equipment and premises. Labels should be unambiguous and in format approved by the company. Sometimes colored labels are used to indicate status. For Example, colored labels for starting materials according to their status: Quarantine - Yellow Approved - Green Rejected - Red 9 HNSIPER

Label of finished product:

Label of finished product 10 Name of product Ingredients Net Content Batch number Expiry date Storage condition Information about manufacturing company ( Lice. No. and Address ) HNSIPER

Label of reference standard:

Label of reference standard 11 Name of material Potency Date of preparation Batch number Shelf-life Storage condition HNSIPER

Specifications And Testing procedures:

Specifications And Testing procedures Introduction Specifications for Raw Materials Specifications for Finished Product Specifications for Packaging Materials Testing Procedures 12 HNSIPER


13 Introduction It is a list of detailed requirements with which product/material used or procedure followed during manufacture need to conform. They serve as basis for quality evaluation. Specifications should be available for : Raw Materials Finished Products Packaging Materials First twos can be referred from their individual monographs from pharmacopoeia. If standard data is not available in pharmacopoeia, then manufacturer can write specification himself. Specifications for packaging materials such as plastic or glass containers and closers etcetera, are not given by any monograph. However certain requirements have been laid down for them in appendix-11 of I.P. HNSIPER

PowerPoint Presentation:

Bureau of Indian Standards (BIS) has prepared specifications for various packaging materials. These specifications are given prefix as “IS”, means ‘Indian Standard’. There are 18210 numbers of Indian Standards. * Certain specifications amongst them are specifically prepared for pharmaceutical industry, while the rest are general specifications. 14 HNSIPER

Specifications for Raw Materials:

Specifications for Raw Materials Generic and chemical name of material Trade name or product code established ny manufacturer Description Name of pharmacopoeia or any other recognized book of standards in which monograph appears or INN (International Non-proprietary Name). Approved supplier Frequency of testing of stored material Special precautions to be taken during storage including safety aspects Date of Issue of specifications 15 HNSIPER

Specifications for Finished Product:

Specifications for Finished Product Generic name of product Trade name Dosage form and Strength Description ( Color, State, Dimension, Taste ) Physical properties ( Weight/Volume (with limit) , pH, Viscosity, Density, Hardness, Friability, Disintegration time, ` Dissolution Time etcetera) Name of Pharmacopoeia as a reference Date of Expiry Precautions during storage including safety aspects Date of issue of specification 16 HNSIPER

Specifications for Packaging Materials:

Specifications for Packaging Materials Below mentioned Indian standards may referred, while preparing specifications for packaging materials: 17 Number of IS Specification for IS 7803 Plastic Containers IS 3692 Rubber Closures IS 1776 Folding Box Board IS 2771 Corrugated Box IS 3101 Collapsible Tubes IS 7852 Eye Ointment Tubes IS 10133 Glass Bottles IS 8970 Paper Aluminum Foil IS 8393 Pilfer Proof Closures IS 1984 Glass Vials HNSIPER

Testing Procedures:

Testing Procedures These are nothing but the procedures for testing raw materials, intermediated and finished products. These procedures are basically based on Pharmaceutics and Analytical techniques. While preparing these procedures Various pharmacopoeia (like IP, BP, JP, EP, USP etc) and other recognized books of standards like drug and cosmetics rules, USNF, other authoritative books on analysis of drugs. 18 HNSIPER

Format For Standard Testing Procedure:

Format For Standard Testing Procedure 19 Name : Pages: Code No. : Shelf Life : Status : Effective Date : STP No. : Review Period : Prepared By Checked By Approved By Signature Date HNSIPER

Master Formulae:

Master Formulae Definition Preparation of Mater Formulae Description Sample of Master Formulae 20 HNSIPER


Definition Master formulae also can be said and written as ‘Master Formula Record’, ‘Manufacturing Formula’, ‘Master Production and Control Record’ (MPCR) etcetera. It is defined as - “ An approved master document that describes the full process of manufacturing for the batch of specific product .” It includes all the materials used in any batch manufacturing and step by step process of manufacturing. 21 HNSIPER

Preparation of Mater Formulae:

Preparation of Mater Formulae Master formulae can be prepared by competent technical staff. It should be reviewed by the heads of production, quality control department and research & development. 22 HNSIPER


Description Name and Strength of the product along with dosage form MFR No. A complete list of all ingredients with their quantity Description of Containers, Closures and Packaging materials to be used Description of all Vessels and Equipments used in the process Processing and Packaging Instructions IPQCs to be exercised during processing and packaging Precautions to be taken during manufacture and storage of semi-finished product including any special storage conditions Reference 23 HNSIPER

Sample Of Master Formulae :

Sample Of Master Formulae 24 HNSIPER

Batch Production and Control record (BPCR) OR Batch manufacturing Record:

Batch Production and Control record (BPCR) OR Batch manufacturing Record Definition Notes about BPCR Contents of BPCR Sample For BPCR 25 HNSIPER


Definition Batch Processing Record can also be said as Batch Manufacturing Record (BPCR) . It is defined as – “ The Batch Manufacturing Record (BPCR) is the necessary quality and GMP documentation for tracing the complete cycle of manufacture of a batch or lot. ” 26 HNSIPER

Notes about BPCR:

Notes about BPCR BPCRs are required to be maintained for each batch of the product manufactured. These should be based on Master Formulae records. Methods of preparation of BPCR should be such that ‘ tra sn cription errors’ do not occur. Before any process begins, a check should be made to ensure that all work stations are clear of previous products, materials and documents. This check should be recorded 27 HNSIPER

Contents of BPCR:

Contents of BPCR The name and batch number of the product Dates and times of commencement, of significant intermediate stages and of completion of production Identification (initials) of the operator(s) who performed each significant step of the process and, where appropriate, the name of any person who checked these operations Quantities of each starting material actually weighed A record of the in-process controls and the initials of the person(s) carrying them The product yield obtained at different and pertinent stages of manufacture Notes on special problems including details, with signed authorization for any deviation from the Manufacturing Formula and Processing Instructions Approval by the person responsible for the processing operations. 28 HNSIPER

Basic Difference B/W MPCR and BPCR:

Basic Difference B/W MPCR and BPCR MPCR is the type of master document, means with the help of MPCR only, the BPCR is prepared… BPCR is unique batch wise, means all batches have their individual BPCR. Moreover BPCR contains ‘Date and Time’, that when the batch was processed. 29 HNSIPER

Batch Packaging Record:

Batch Packaging Record Introduction Contents of BPR 30 HNSIPER


Introduction In fact, BPR is a part of BPCR. These records are based on packaging instructions. One important operation that should be carried out before packaging operation is line purging (clearance). 31 HNSIPER

Contents of BPR:

Contents of BPR Name, Batch number and Qty. of bulk finished product to be packed Theoretical and Actual Yield and Reconciliation The date and time of the packaging operation The name of responsible person and his initials Details of packaging instructions like equipments and packaging lines used Qty. along with identification of different printed packaging materials issued, used, destroyed and/or returned to store and reconciliation In any case of problems, if any deviation made, written authorization for the same 32 HNSIPER

Site Master File:

Site Master File Introduction Inclusions of Site Master File HNSIPER 33


Introduction Site Master File is a document, which gives a complete information regarding a site of pharmaceutical plant. This document generally should not be very massive, like running into more than 100 pages. M.H.R.A. (Medicines and Healthcare products Regulatory Agency), a government agency of U.K., has given certain guidelines for length of the format for it. 34 HNSIPER

Inclusions OF SMF:

Inclusions OF SMF The Information about - Company Personnel Premises and Equipment Documentation Production Quality Control Contract manufacture and analysis Distribution, Complaints and Product Recalls Regulatory inspections and self-inspections Details of Annual Product Review Change Control System Technical Quality Agreement for Contract Manufacturing (Technical Agreement, Quality Agreement) 35 HNSIPER


References How to Practice ‘GMP’, By P. P. Sharma. Pharmaceutical Quality Assurance, By Manohar A. Potdar. Web Search Engines : Bing & Google Web Encyclopedia : Wikipedia 36 HNSIPER

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