The basic rule of good manufacturing practice (GMP) regulations is that the pharmaceutical manufacturer must maintain proper documentation and records and it is mandatory to define the specifications, procedures for all materials, methods of manufacture, methods of control and latest version procedures should be known to authorize personnel to conduct analysis or any other work as per the procedure.

The QA authority need to ensure the existence of documented evidence, traceability, and to provide records and an audit trail for issuance of these documents to authorize persons. In most of the times a controlled excel or generic system is used to keep summary of all documents, but it will not satisfy the regulatory norms. Document management is so important in pharma that, it is must to have a good Document Management system (DMS) made for pharma complying these regulations.

Regulatory inspectors, during their inspections of manufacturing sites, often spend much time examining a company’s documents and records. Effective documentation enhances the visibility of the quality assurance system. Considering above facts, it is important to harmonize GMP requirements related to ‘documentation and records,’ followed by a meticulous review of the most influential and frequently referred regulations.

Most of the pharmaceutical companies have more than one location and there are few or more documents which are common across, and these documents need to be harmonized and QA should ensure a common version is being used across. A manual method is extremely time consuming and person dependent and may have risk for audit observations. The issuance of latest version of document across all sites can be controlled by DMS (Document Management System), a DMS which is built for Pharma GMP operations and not a DMS which is used by another industry domain.

Some examples of documentations used in the pharmaceutical environment which need to be harmonized and published on are Laboratory Note Books, Batch Record, Bills of Materials, Specifications, Policies, Protocols, Standard Operating Procedures (SOPs), Work Instructions, Test Methods, Check Lists, Forms/Log Sheets, Training Assessments, Electronic and Hardcopies of Quality Records, Certificate of Analysis, Validation Documents etc.

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