Gmp Certification Consultancy

GMP or Good manufacturing practice is a theoretical standard that assures products quality. It establishes an operational requirement and condition essential to ensure proper hygiene over the food and supply chain and for production. GMP certification mainly deals with issues such as record keeping, documentation, sanitation, personnel qualifications, equipment verification, cleanliness, complaint handling, sanitation, and validation process.

These requirements are designed in a way that proactively controls risks to end-users from products and items out of production from various industries like Cosmetics, Food & drugs, Pharmaceuticals, Medical Devices, and more.

Purpose of GMP

The primary purpose of providing GMP certificates to pharmaceutical companies is to take all important precautions to prevent the risk of accidents and errors in the production of pharmaceutical products.

• Unexpected uncleanness
• The right use of ingredients in the product
• Incorrect containers labels

Understanding GMP Guidelines for Certification Holders

As per World Health Organization guidelines for GMP practices, many nations have defined their necessities for the GMP based on the guidelines of WHO. Some have fit their preconditions, just like in the EU (European Union), (ASEAN) Association of South-East Asian Nations, and through the Pharmaceutical Inspection Convention.

The GMP guidelines need a quality way of dealing with manufacturing and empowering companies to restrict/eliminate instances of misunderstandings, contamination, and errors. This protects the consumer from purchasing an item that is not very compelling or risky.

Documents Required for the GMP Certification

Given is the list of documents required:

•  Manufacturing Licence copy
•  Applicant name with address, fax, phone, and email
•  Site file
•  Approved items list
•  Manufacturing procedure
•  Master manufacturing formula
•  Stability study check for 3 batches (Batch size, No, manufacturing date, expiry date, and stability study condition)
•  Final Product Specification & Method of Analysis
•  Validation report of analytical method
•  Process the validation report for 3 batches
•  Qualification, experience & approval status of staff
•  Technical staff list
•  List of STPs and SOPs
•  List of instruments and equipment
•  Water system schematic diagram
•  Layout of Manufacturing Plant
•  Safety proof
•  Product sheet

Benefits of GMP Certification

All pharmaceutical & medical device manufacturers have to follow GMP rules though some have made their guidelines that resemble the legislation.

•  Entitle certification holders to look for great creations
•  Identify manufactures & management issues
•  Save cost
•  Enhance public image and credibility
•  Improves consumer confidence in your products
•  Compliance with laws & guidelines
•  Reduce operating costs because of rework or penalties for non-compliance
•  Lower safety risk in the product safety and quality
•  Helps to improve export opportunities
•  Lower inspection duplication