Site master file: it is a document, which provides all information of a pharmaceutical plant. There are followings content to be needed to prepare a SMF.

1. General information, it includes information related to organization, mfg activities, name and address, type of products description of site employee details external technical support, quality management system.
2. Personnel, organizational chart, Qualification, experience and responsibilities of key personnel Training , health requirements and personnel hygiene clothing
3. Premises and equipments: Description of manufacturing area , nature of construction and finish, brief description of ventilation, special areas, water system, maintenance of premises, major production and laboratory equipments, maintenances  of equipments, calibrations and sanitizations.
4. Documents, preparations, revision and distributions of documents,
5. Production, Brief description of production operations, Handling of materials, handling of rejected materials and product, brief description of general policy of process validation.
6. Quality control, quality management system
7. Self inspection, self inspection program.
8. Change control, it is a document for review, approval and implementation of any change in validated system, equipment, process and materials Etc.
9. Protocols: A written plan stating how validation will be conducted and defining acceptance criteria. For example, the protocol for a manufacturing process identifies processing equipment, critical process parameters/operating ranges, product characteristics, sampling, test data to be collected, number of validation runs, and acceptable test results.

Preparation, issues and uses of Documents
Documents should be carefully and logically specify to prevent wrong uses. All necessary information’s are written unambiguously. Each document includes:

1.       Company name
2.       Purpose and title of documents
3.       Identification No and revision No.
4.       Date of authorization
5.       Date of review
6.       Signature of prepared by, checked and authorized by.
7.       Distribution list
8.       Page no.
9.       Reason for revision should be documented.
10.   Abbreviation and reference

Each document is clear and computerized so that it is readable, issued documents signed by a concern person to indicate a verified issue. Any correction is made by cutting with single line with signature and date, do not overwrite. Document to filled have a sufficient space, ball ink pen should be used for hand written filling.

Document control
The process by which a manufacturer ensures that all procedures used and documents generated in G.M.P. – related actions are current, accurate and approved.
Purpose of document control to control issuance, possession, use and revision of master documents including
Standard Operating Procedures
Data collection forms
Validation Protocols
Master formulae
Batch records
Function of Quality Assurance Unit

Initially document is prepared by concern department as draft and draft is reviewed by dept. head and final draft is send to QA department that convert a draft to a final documents  checked and approved by authorize person. Control copies are issued to concern department and issuance records are maintained. After approval of documents such as sops quality assurance must ensure that all users/concerned department gets training before the implementation of the sops record of such training must be maintained. A training co-coordinator preferably the head of user department or any designated individuals shall be responsible for organizing the training. After successful implementation of training on any sops, the sops become effective.

Original sops are stamped as “MASTER COPY” with red ink, master copy are stored under supervision and photocopy of master copy duly stamped as “CONTROL COPY” in blue color. Sops distribution list should be maintained for issuance records, change in sops need to initiated change request and all issue copies are retrieve and new one implemented with training.

Implementation of a Good documentation practice for pharmaceutical products will facilitate compliance with GMP and Regulatory bodies. The central goal of a GDP is to define the manufacturers system of information & control, to minimize the risk of misinterpretation & errors inherent in oral or casually written communication, to provide unambiguous procedures to be followed to provide confirmation of performance, to allow calculations to be checked & to allow tracing of batch history and also ensure Quality of products.

1.WHO module 12 part-2 January 2006
2.Manohar A potdar ‘pharmaceutical Quality assurance’ Nirali prakashan.



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