11/5/2018 FDA process­validation ­ GMP Good Manufacturing Practice SOP

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Standard Operation Procedures (28) FDA process-validation
Checklists (4)
Master Plans (9) What Does the Revised FDA Process Validation mean to You
Quality Contracts (4)
Free Documents (2) There has been several incidents where low quality drugs are manufactured and marketed despite being
produced under “validated” process. Such unfortunate incidents led to complaints and product recalls in
many countries. After studying the FDA Process Validation Guidance, 1987 for 22 years, U.S. Food and
Drug Administration took a rational and scienti䁨쀀c approach to improve and secure the quality of
Frequently Asked Questions
pharmaceutical products.
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Company Pro䁨쀀le According to FDA, quality and safety of drugs can be enhanced by making each step of the manufacturing
process extremely speci䁨쀀c and controlled, rather than randomly testing a sample from the batch of
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䁨쀀nished products. Therefore the revised version focuses on Life Cycle Approach for process validation
Privacy Policy - Datenschutz where right from the process design to every step in the production is giving a scienti䁨쀀c evidence that the
Contact manufacturing process is consistently delivering high quality and safe products.
Let’s talk about the tasks carried out and processes scrutinised in each of these steps.

Regulation and Guides

Stage 1: Process Design
FDA
EMEA Knowledge and understanding of manufacturing process is extremely important to ensure the quality. The
International Regulatory Links process of commercial manufacturing is designed through the application of scienti䁨쀀c knowledge gained
during laboratory scale and pilot scale manufacturing. You have to identify and state the sources of
FDA Regulatory Links
variability and their impact on quality of the product. The critical processes that may pose threat to quality
Organisations and safety could be for example analyzed with PAT (Process Analytical Technology) and consistent
News & Trends monitoring through SPC (Statistical Process Control) is desirable.
The primary objective of FDA process validation for stage 1 is to de䁨쀀ne and control manufacturing process
GMP Guide such that the sources of variability don’t have any negative impact on safety and quality of the products.
The FDA - The Food and Drug
Administration Stage 2: Process Quali䁨쀀cation
Guide for GMP Documentation and
Well, you have designed the process and elaborated it enough for employees to carry out the activities.
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But what’s the proof that your process is fully capable of large scale manufacturing safe drugs with high
Compliance quality? It is ensured in two simple steps.
GMP Good Manufacturing Practice First, the FDA process validation requires each of your facility, equipments, process and utilities should
GMP Audit (Audit Personnel, Quality qualify for GMP. The analytical and sampling methods used in your company should prove to be within
Documents) FDA acceptable operating range. If any of these activities fails to meet the standards, it will be moved back
to process design stage to carry out required changes.
cGMP for Quality Assurance
If everything is found to be acceptable, the process is fully documented to elaborate the necessary
GMP Complaint conditions for manufacturing (temperature, humidity, purity of water, vibration, light, variation in electric
GMP FDA Inspection supply, etc.), processing parameters and speci䁨쀀cations about raw materials, collection and evaluation of
FDA process-validation data. The document should also tell about the tests employees have to perform at various steps and the
acceptable results for those tests. You should have clear statistical data to prove that your manufacturing
GMP Failure Investigation
facility constantly produces with desired quality.
GMP-OOS
Pre-Approval-Inspection The FDA process validation guidance instructs on releasing the products in batches.  
GMP Supplier-Audit
GMP Technical Agreement
GMP Validation  
GMP Warning-Letter
Stage 3: Continued Process Veri䁨쀀cation

It is the last step of FDA process validation before the product is released into market. You have to
continuously verify that the entire manufacturing process is controlled and consistent, and exactly
matches with what was documented in the stage 2. If any deviation is detected in the process, use
statistical data to evaluate the undesired process variability. If the statistical results are beyond
acceptance, you have to instantly notify it to the operations in-charge and process re-quali䁨쀀cation activities
must be considered.
Industry has taken FDA process validation approach very seriously and they must comply with it along with
the Codes of Federal Regulation (CFR). Demonstrating process knowledge and continuously verifying the
processes will ensure that the lot of products going out of your factory is of acceptable quality.

Image Credit
U.S. Food and Drug Administration, www.fda.gov

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