Good Documentation Practice


Basic Concepts of Good Documentation Practice in
Pharmaceutical Industry



  
Why Document?
In the pharmaceutical industry it has been said that,

“If it isn’t documented, it didn’t happen”

Therefore, in the pharmaceutical and medical device industry, we document to provide written proof that something happened.



What is Good Documentation practice?

Good Documentation practices are the guidelines which one follows in recording raw data entries in a legible, traceable and reproducible manner.
Good Documentation Practices are commonly referred to as GDPs.

Change Management!!!


“A systematic approach to proposing, evaluating, approving, implementing and reviewing changes.”
All changes should be formally requested, documented and accepted by representatives of Production, QC/QA, R&D, Engineering and Regulatory Affairs as appropriate.
The likely impact (risk assessment) of the change on the product should be evaluated and the need for, and the extent of Re-validation discussed. The change control system should ensure that all notified or requested changes are satisfactorily investigated, documented and authorized.”
All changes that may affect product quality or reproducibility of the process should be formally requested, documented and accepted. The likely impact of the change of facilities, systems and equipment on the product should be evaluated, including risk analysis. The need for, and the extent of, re-qualification and re-validation should be determined.”

Changes are classified based on their impact.

Minor change: change which fulfills the conditions of Appendix I of Regulation (EC) no. 1084/2003 or which affects the attributes of a system, facility, apparatus, material/product or procedure/process. Impairment of the product quality/process reliability is not likely. Minor changes may require notification to the regulatory or supervisory authorities.

Major change: change which cannot be classified as a minor change or which may affect the critical attributes of a system, facility, apparatus, material/product or procedure/process. Impairment of the product quality/process reliability is likely. Major changes may require authorization by the relevant regulatory or supervisory authorities and/or prior revalidation or requalification.


What is Deviation?
Deviation is nothing but when action departing from an established procedures or accepted standards.
Deviations are measured differences between observed value and expected or normal value for a process or product condition, or a departure from a documented standard or procedure.


A deviation may occur during sampling and testing, raw materials- and finished product acceptance and manufacturing.



What is Incident?
Incident:
Is an event that may occur in facility, manufacturing operation /process or written procedures, which is directly or in-directly related to plant operations. An incident does not have any impact on the product quality.




Importance of Training!!!


Training is teaching, or developing in oneself or others, any skills and knowledge that relate to specific useful competencies. Training has specific goals of improving one's capability,
Training plays a vital role in any industry to improve performance & achieve compliance.
On Job Training includes
1.       Training personnel staff.
2.       SOP training,
3.       Guideline training,

What is SOP?


Standard Operating Procedure is a set of written instructions that document how routine/repetitive activity will be performed which to be followed by employees in an organization.



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