Industrial Pharmacy/2013

Doc. No. Chp.IP.9/03/ 2013

Good Document Practices In Pharmaceutical Industry

Document: The document is, concise, legible, accurate and traceable recorded information (meaningful data) on a supporting medium, which could be in paper form, CD, computer files, or microfilm Now we come to these basic elements of the document Concise: Means, it must tell the entire story and understandable for an ordinary reader Legible: Means, it must be readable by the relevant persons and there shouldnt be any misleading statements. Accurate: Means, It must be error free, data should be recorded as soon as possible after the happening along with proper units and must be reviewed and counter checked by at least two different personals (one from the higher management of the same department and one from the management of quality control department) Traceable: Means, a complete description, of the personals who recorded the data of the document, when it was recorded, what was the method to record, and where this data is stored? A document system is an interdependent, interrelated set of documents, each with a defined purpose and a consistent format Documentation: The process of maintaining the documents of an organization to answer certain quires/investigations, to analyze the quality, to standardize the procedures, to evaluate the performance, to sustain the efficiency, to understand/demonstrate the functional/operational activities, to rationalize the incidences to facilitate the inspection/audit and to keep complete history of processes/activities is termed as documentation. Or in simple words, documentation is meaningful, utilizable and presentable form of documents. (Having the documents but not proper documentation = failure) What is the objective of documentation? Why it is necessary?
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Industrial Pharmacy/2013

Doc. No. Chp.IP.9/03/ 2013

Good Document Practices In Pharmaceutical Industry

The objectives documentation of are: It is an important tool of quality assurance. It helps to establish effective quality system, instructions and procedures in accordance with the requirements of international standards. Correct, complete, current, and consistent information effectively meets customer and stakeholder' requirements. To define the specifications and procedures for all materials and methods of manufacture and control To ensure that all personnel concerned with manufacturing know what to do and when to do it. It involves the systematic interaction of people, events and documents to create the records of the organization. To ensure that authorized persons have all the information necessary to decide whether or not to release a batch of a product. To ensure the existence of documented evidence, traceability, and to provide records and an audit trail that will permit investigation and to ensure the availability of the data needed for validation, review, and statistical analysis. No matter what type of product is developed and produced, it must be safe, effective and fit for its intended use and this can only be supported with proper documentation. To declare product standards and describe how to monitor, test and judge for compliance with these standards. Why Good Documentation is essential in pharmaceutical industry? Because it is an essential part of the quality assurance system and should exist for all aspects of GMP (reference: WHO GMP, Volume 2) Good documentation is an expected practice by the pharmaceutical industries to ensure the quality of the product directly concerned with the public health. Good Documentation Practices, in brief, enable communications of intent and consistency of actions (ISO-9000: 2000)

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Industrial Pharmacy/2013

Doc. No. Chp.IP.9/03/ 2013

Good Document Practices In Pharmaceutical Industry

When an organization develops and keeps the documents that describe (1) How the Quality Management System is applied to a specific product? (2) Establishment of documents on product requirements (specifications). (3) Establishment of documents to provide information about how the organization perform activities and processes (procedures) (4) Establishment of documents to provide objective evidence performed or results achieved (records), Then the organization management can claim that they fulfill the good documentation practices requirements and can be certified for the international standards by the competent authorities. GDP allows the data creator to use the material in the future, when the data creation process has started to fade from memory. GDP enables other to explore the resource fully, and provide sufficient details to allow the personals who have not been involved in the data creation process to understand the data collection and the process by which it was created and how it is used. It provides basic guidelines and standard ways for the correction of errors

What are the basic types of documents? Basically there are three types of Documents 1. Commitment Documents: Relationship between industry and the regulatory authorities, employees, other manufacturers, suppliers, vendors, distributors and different unions. Commitment document presents the organizational goals. It has policies and legal documents of the organization (A document to establish the organization interpretation and attitude towards the regulatory body ). It includes: o Employment contract o Manufacturing licenses o New Drug Applications (NDAs), o Drug Master Files (DMFs). o Product registration

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Industrial Pharmacy/2013

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Good Document Practices In Pharmaceutical Industry

o Patent rights o Formulation and design registrations o Deals/agreements with other organizations o Authority declaration documents o Partnership and shareholder contracts etc. 2. Directive Documents: Relationship between the Management and Employees. It includes: o Job descriptions and responsibilities of all the employees o Guideline (it provides recommended practices and instructions o Standard operating procedures (SOP): (To provide detailed instructions on how to implement a process or perform a specific activity) o Manual: To provide information on how a system or equipment operates o Specifications o Hierarchy of the organization and reporting system/channel o Equipment installation manuals o Machinery/equipments result interpretation charts o Calculation conversion charts o Laboratory chemicals directions and guidelines o Calibration guidelines o Evaluation guidelines o Protocols 3. Record Documents: Relationship between the Employees and the Work they perform. Record document, is a document stating results achieved or providing evidence of activities performed It includes: o Daily work sheets/ logbook o Employees history o Equipment history o Materials description o Purchase records

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Industrial Pharmacy/2013

Doc. No. Chp.IP.9/03/ 2013

Good Document Practices In Pharmaceutical Industry

o Finished goods description o Selling records o In process evaluation record o Equipment repair and maintenance record o Atmospheric records o Batch Production Records (BPRs) o Inspection records o Audit records o Forms and templates (Pre structured documents with blank spaces designed for insertion of required information).

What are the major parts of a standard document for GDP? Along with the main body of a document, addressed/approved by whom and addressed to whom, a standard document must also include: o Document number/continuity number (in case of updating) o Document type o Document creator o Document recorder o Documentation time and date o Document evaluator o Document reviewer o Document verifier o Date and time of re-evaluation Usually these parts are placed at header/footer position of a document. A good document also contains little space for important notes and remarks.

How and by whom documentation is done? Usually the documentation is done by the management of the respective department under the supervision of quality assurance department. Quality assurance department provide the basic lines/chart/form about the documentation and respective department create relevant document by its proper filling or recording the information required.

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Industrial Pharmacy/2013

Doc. No. Chp.IP.9/03/ 2013

Good Document Practices In Pharmaceutical Industry

Once the document is prepared, it is verified by the respective departmental head/manager and then must be counter checked before sending to quality assurance department or before displaying to respective area. In case of record documents, the entries must be done as soon as possible and properly signed. Records should be made or completed when any action is taken and in such a way that all significant activities concerning the manufacture of pharmaceutical products are traceable. There should not be any irrelevant entry or box left blank. Instead of leaving it blank, it must be written as NOT APPLICABLE (N/A). Data (and records for storage) may be recorded by electronic data-processing systems or by photographic or other reliable means. In case when the record is maintained electronically, master formula and detailed standard operating procedures related to the system in use should be available and the accuracy of the records should be checked. If documentation is handled by electronic data-processing methods, only authorized persons should be able to enter or modify data in the computer, and there should be a record of changes and deletions. Batch records stored electronically should be protected by back-up transfer on CD, microlm, paper print-outs or other means. It is particularly important that, during the period of retention, the data are readily available. Records should be retained for at least one year after the expiry date of the nished product How to correct a document To correct a document while counter checking or evaluation, mistakes should be properly highlighted and a line should be marked through the mistake along with a correction above the mistake and must be signed with time and date. If space is not enough to write the notes, it can be written somewhere below the document where the space is available with the guiding mark like * or or or or sometimes simply an arrow. All types of handwritten entries must be in ink and should not be in lead pencil or any removable medium. WHO and drug regulatory authorities discourage the use of

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Industrial Pharmacy/2013

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Good Document Practices In Pharmaceutical Industry

removing/ erasing practices on documents. Similarly the use of whitening liquids/compounds to hide the mistake is also not encouraged . Required documents for GDP As per WHO guideline for pharmaceutical products, the plant management should ensure that the following documents are prepared and available: 1. Specifications including tests on identity, content, purity and quality for starting and packaging materials and specifications for intermediate, nished, and bulk products. 2. Specifications of water, solvents and reagents (e.g. acids and bases) used in production. 3. Pharmacopoeias, reference standards, and other reference materials should be available in the quality control laboratory. 4. A formally authorized master formula should exist for each product and batch size to be manufactured. 5. Formally authorized packaging instructions should exist for each product, pack size and type. 6. A batch processing record should be kept for each batch processed. 7. Before any processing begins, a check should be made and recorded. (That the equipment is clean and work station are clear of previous products, documents, or materials not required for the planned process) 8. A batch packaging record should be kept for each batch or part batch processed. 9. Batch number allocation should be recorded, e.g. in a logbook. 10. Analysis results and the tests performed should be recorded. 11. Records should be maintained of the distribution of each batch of a product in order to facilitate the recall of the batch if necessary. 12. Records should be kept for major and critical equipment of:
o o

Validations and Calibrations Maintenance and repair operations and cleaning

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Industrial Pharmacy/2013

Doc. No. Chp.IP.9/03/ 2013

Good Document Practices In Pharmaceutical Industry

13. The use of major and critical equipment and the areas where products have been processed should be recorded in chronological order. 14. Standard operating procedures and associated records of actions taken should be available for:
o o o o o o o o o

Equipment assembly and validation Analytical apparatus and calibration Maintenance, cleaning, and sanitization Personnel matters including qualification, training, and hygiene Environmental monitoring Pest control and assigning responsibility for cleaning and sanitation Written release and rejection procedures Complaints, Recalls, Returns and Sampling For testing materials and products at different stages of manufacture describing the methods and equipment to be used.

o o

For describing the details of the batch (lot) numbering system For the internal labelling, quarantine and storage of starting materials, packaging materials and other materials

For the receipt of each delivery of starting material and printed packaging material Some suggested readings

Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use (US FDA, Chapter 4. Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS WHO. Good Manufacturing Practices for Pharmaceutical Products: Main Principles. EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use. Volume 4.

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Industrial Pharmacy/2013

Doc. No. Chp.IP.9/03/ 2013

Good Document Practices In Pharmaceutical Industry

Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostic Reagents (Japan MHLW. Chapter 2, Section 2) Standard Operating Procedure for Use and Maintenance of Laboratory Notebooks and Project Binders. Good Documentation Practices, Hurd & Don.

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