WHO - GMP Certification

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WHO - GMP Certification

Overview of GMP Certification

GMP stands for Good Manufacturing Practice, & the term is used globally for managing the control and management of manufacturing, testing and overall quality of pharmaceutical products. It defines certain guidelines that talks about the quality assurance approach. GMP certification ensures that products are produced following the quality standard norms.

Joint Commissioner is authorized by Commissioner, Food & Drug Administration, to sign & issue the certificates under the WHO-GMP certification scheme. GMP certification deals with issues like documentation, record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, sanitation, complaint handling, and process validation.

GMP Certification requirements are not peculiar in any sense instead they are open ended and easy to implement also these requirements give liberty to the manufacturer to decide individually how to efficiently implement the necessary controls.

What is the Purpose of Goods Manufacturing Practice?

The main purpose of Goods Manufacturing Practice is to reduce the amount of risk involved in the production of pharmaceutical items. Pharmaceutical items include risks such as: (a) unexpected uncleanness in the product can badly affect the health which can further lead to death; (b) incorrect labels on containers which simply implies that patient is consuming the wrong medicine, (c) too much active or too less ingredient, (d) causing ineffective treatment or adverse effects, etc.

WHO GMP has many authority under it such as covering all aspects of production, from the starting material, details regarding areas and equipment to the training and personal hygiene of staff. It provides the complete details regarding the procedures that yield the finished product and could affect the quality of it.

What does GMP Guidelines Directs the Certification Holders?

WHO (World Health Organization) has formed certain guidelines for good manufacturing practices. Numerous nations have defined their own necessities for GMP based on WHO GMP. Others have fit their prerequisites, for instance in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention.

GMP guidelines require a quality way to deal with manufacturing, empowering organizations to limit or eliminate instances of contamination, misunderstandings, and mistakes. This shields the consumer from buying an item which is not compelling or even risky.

Most GMP prerequisites are extremely extensive and open-ended, permitting every maker to choose independently how to best actualize the essential controls. This gives a lot of adaptability, yet additionally necessitates that the producer decipher the prerequisites in a way which makes sense for every individual business.

What are the Benefits of GMP Certification?

Every pharmaceutical and medical device manufacturers follow GMP rules and procedures while some have created their own guidelines that correspond with their legislation.

  • Empower certification holders to opt great creation,
  • Timely identify of manufactures and the management issues,
  • Compliance with important laws and guidelines,
  • Improve overall credibility and public image,
  • Reduce safety risk in product quality and safety,
  • Increases consumer confidence in your products,
  • Helps to decrease operating costs due to rework and penalties due to non-compliance,
  • Helps boost export opportunities,
  • Reduced duplication of inspections,
  • Cost saving.

WHO GMP  Benefits For The Manufacturer

One of the primary benefits is significantly improved quality systems and quality compliance at the manufacturer. We have seen these improvements in the months leading up to GMP certification and continuing during the years immediately following GMP certification.

GMP Benefits For The Customer  

Customers will typically modify their oversight of manufacturers that have been GMP certified. Customers are aware that in order to be certified, the manufacturer must have systems in place and provide evidence that non-conformance and changes that require customer notification are handled appropriately. This assurance is typically not obtained through a one-day supplier audit that pharma companies carry out; rather, it is obtained as a result of thorough, multiple day audits of manufacturer as part of a certification audit program.

What are the Documents Required for GMP Certification ?

  • Copy of PAN Card  (Proprietor/Partner/Director)
  • Copy of Aadhaar Card  (Proprietor/Partner/Director)
  • One copy of sales bill One copy of purchase bill
  • GST Certificate (Optional)
  • Certificate of Incorporation  (In case company is Private Limited Or LLP Or Limited)
  • Company Pan Card  (In case company is Private Limited Or LLP Or Limited or Partnership Firm)
  • Partnership Deed  (In case partnership Firm)

What are the Basic Principles that GMP Guidelines Seeks to Obey?

  • Pharmaceutical assembling office must maintain their manufacturing zone clean and spotless. Controlled ecological conditions should be maintained so as to prevent cross contamination of nourishment or medication item from adulterants that may render the item perilous for human utilization.
  • Manufacturing process is unmistakably characterized and controlled. Every single procedure must be approved to guarantee consistency with details.
  • Manufacturing processes are controlled, and any progressions to the procedure are assessed. Changes that affect the nature of the medication are approved as per requirement.
  • Directions and techniques are must be written in clear and unambiguous manner. Administrators must be prepared to conduct document procedures.
  • Records must be made, manually or by instruments, during manufacture that demonstrates all the steps required by the defined procedures and instructions Moreover, all deviations are to be investigated and documented.
  • Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
  • Complaints about items are to be analyzed, where the reasons for quality imperfections must be investigated and suitable measures are taken concerning the inadequate items & to prevent repeatation.

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