GMP Certification

GMP Certification – GOOD MANUFACTURING PRACTICES

The GMP refers to Good Manufacturing Practices (GMP) regulations promulgated by national and international guidelines or standards to achieve GMP Certification. i.e. WHO.

These requirements, require that manufacturers to ensure that their products are safe, pure and effective.

This in turn, protects the consumer from purchasing a product which is not effective or even dangerous.

Structure

GMP follows  the structure of QMS – ISO 9001.

Requirement

GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation and complaint handling.

Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls.

This provides not only much flexibility but also; requires that the manufacturer interpret the requirements in a manner which as a result; makes sense for each individual business.

GMP 0r cGMP

Since; GMP is also sometimes referred to as “cGMP“. The “c” stands for “current,” reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the requirements of standard.

Systems and equipment used to prevent contamination, mix up and errors, which may have been “top-of-the-line” 20 years ago, may be less than adequate by today’s standards.

Steps to Apply for Certification

HOW TO APPLY

• Inquiry: Submit the inquiry form with detail of organization as per required questions in the form.

The correct information shall enable us to provide the cost effective and competitive proposal of certification of three years.

• Proposal: Estimated cost of services is provided for contract.
• Contract: A contract issued to initiate the certification services accordingly in which organization provided three years certification terms of references.

Organization inform SAI to conduct audit as per mutual understanding and readiness of system.

• Audit & Certificate: Audit performed reference to the observation and findings closing certificate against successful achievement of requirements certificate issued.

That requires system to sustain for continuous monitoring surveillance audits further to continue the GMP certification.

Swiss Approval International assures certification, giving to organizations the suitable passport for International market, ensuring with accuracy and independence of principles and rules established by the local and international authorities of GMP.