The role of Good Documentation Practices on Compliance Activities

The role of Good Documentation Practices on Compliance Activities.

An acceptable definition of Good Documentation Practices (GDP) would be the prescribed standards by which documentation is created and maintained in the pharmaceutical industry. The FDA has set some GDP standards, but these are not the only GDP standards. There are others that come under the current Good Manufacturing Practice (cGMP).

Apart from the obvious reason of ensuring smoothness of documentation and records; another very important reason for which pharmaceutical, bioscience and healthcare companies –including their vendor partners –are obliged to observe GDP is for the reason that they invite warnings or penalties from the FDA if any noncompliance is brought to light.

Why should companies implement GDP?

The World Health Organization (WHO) has set out the purposes for which companies need to implement GDP. These are:

• It helps define the specifications and procedures for all materials and methods of manufacture and control

• GDP has to ensure that all concerned personnel know what to do and when to do it

• GDP gives the qualified and authorized persons in the organization the information using which they can decide whether or not to release a batch of a drug for sale

• It offers documented evidence, traceability and an audit trail, which will go a long way in ensuring a smooth investigation when it is necessary.

• GDP makes sure that the data needed for validation, review and statistical analysis is available with the company.

Why is compliance with GDP important?

The rationale for which the WHO has mandated the use of GDP is self-explanatory. As we have seen, the FDA and other regulatory bodies have made compliance with GDP practices mandatory. The fact of its being mandatory is the strongest reason for compliance. The aim of making compliance with GDP mandatory is to ensure that quality and other important aspects of medical devices, such as standards, are strictly adhered to.

When there is compliance with set standards for documentation; there is all-round ease and convenience in reading and understanding important documents. In order to ensure this, the following requirements are necessary to ensure quality control and assurance:

• Standard Operating Procedures (SOPs)
• Specifications
• Protocols
• Policies
• Bills of Materials (BOMs)
• Batch Record Forms
• Work Instructions (WIs)
• Checklists
• Electronic and hardcopy Quality records (e.g. non-conformance, corrective and preventative
• Forms/Log sheets
• Test Methods
• Training Assessments


Thanks & Best Regards,
John Robinson
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

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