GOOD DOCUMENTATION PRACTICE IN PHARMACEUTICALS
Malhotra college of pharmacy
RGPV Bhopal, India
Document is any written statement or proof of any activity in pharmaceuticals. Documentations are 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. Documents are a mirror to show actual image of any pharmaceutical company. Documents and products are produced in pharmaceuticals but regulatory bodies are interested to see documents first. Different documents can describe the different activity in pharma and its actual image. Various documents are producing by pharma company would be discussed below. Due to the importance given to documentation in pharma “good documentation practices” is required. Good documentation is a systematic procedure of preparation, checking, verifying, issuing, storing and reviewing of any documents. Batch record is an important document kept along with reserve sample until one year of expiry of the product, and final products are release only after proper review of BMR, even after testing of Product from QC, product would not be released without review and completing of BMR and other documents .every activity should be available written form as SOPs is a requirements of GMP. Control of document is also an important part of GDP to reduce error and misuses of any documents. Master copy for all activity should be prepared such as SOPs started from Draft copy and finalizes after checking and reviewing and Approved by QA documentation. Final copy should be printed as Master copy and stamped as “master copy” by red ink. A photocopy of master copy should be issued to concern department with stamped “control copy”. A record should be maintained for issuing any documents with sign & date. Every document should have effective date, review date and revision no.
Reference Id: PHARMATUTOR-ART-1288
The GDP can be defined as “Good documentation practice is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO.
Clearly written documents prevent errors of various activities in pharma each and every activity is written in specific documents such as SOPs and strictly followed. Spoken communications may be create errors so that all important documents such as Master formula record , procedure and record must be free from errors and Documented.
It is difficult to make a list of required documents and totally depend upon Companies activity or environment. Followings are the activity factors considered during designing of any documents.
1. Type of formulation
2. Country requirements
3. Availability of ERP or SAP system
Purpose of Documentations
• Defines specifications and procedures for all materials and methods of manufacture and control
• Ensures all personnel know what to do and when to do it
• Ensure that authorized persons have all information necessary for release of product
• Ensures documented evidence, traceability, provide records and audit trail for investigation
• Ensures availability of data for validation, review and statistical analysis.
Classification of Documentation
Following are the classification of Documents
• For organization & Personnel.
• For Buildings & facilities
• For Equipments.
• For Handling of R.M.& P.M.
• For Production & process control.
• For Packaging & Labeling control.
• For Holding & Distribution
• For Laboratory Control.
• For Records & Reports.
• For Return & Salvaged finished products.
Type of documents used in pharmaceuticals
• Specifications: as per MHRA Specifications describe in detail the requirements with which the products or materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation. We need specification for:
1. Active and inactive materials
2. Primary printed and packing materials
3. Intermediate and semi finished product
4. Finished product
• SOPs: it is a written, authorized functional instruction used as a reference by the person responsible for performance and are also used for training new operators in the performance of the procedure.
• Test method: it is a written and approved documents describe the detailed testing procedure.
• List: Documents contain a catalog of any object such as list of equipments.
• Certificates of Analysis: it is an authentic documents shows the analytical reports and decision of acceptance/rejections
• Organ gram
• Job description
• Batch Manufacturing records: it is an important document issued for every batch of product to assure, review and record keeping of any product batch. There are following major content of BMR.
1. Name of product, generic name, strength, shelf life, manufacturing date and exp date.
2. A complete list of ingredients with full description, codes and quantity to be issued.
3. A statement for theoretical yield and reconciliation.
4. A complete MFG and control instructions, sampling and testing procedure, specification and precaution to be followed.
5. A statement for processing location and equipment.
6. The method or reference to method to be used for preparing the critical equipment including cleaning, assembling, calibrating and sterilizing.
7. Dates and time of all activities
8. Line clearance procedure in every steps
9. Labeling control and specimen for coding in primary, secondary and tertiary packing materials
10. Deviation record
11. Result of examine made.
Page of BMR
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