Good Manufacturing PMP (Good Manufacturing Practice)

Table of content
Certification Overview
Certification Process
Costs
Benefits of the GMP

Certification Overview:

 

Good Manufacturing Practice (GMP) is defined as “That part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.” The principles and guidelines for GMP are stated in two Directives; Directive 2003/94/EC for medicinal products and investigational medicinal products for human use and Directive 91/412/EEC (http//ec.europa.eu)concerning veterinary medicinal products. Compliance with these principles and guidelines is mandatory within the European Economic Area. Detailed guidelines in the form of the Guide to Good Manufacturing Practice provide interpretation of the principles and guidelines and these in turn are supplemented by a series of annexes which modify or augment the detailed guidelines for certain types of product, or provide more specific guidance on a particular topic. They are developed by the GMP inspection services group and are published as Volume 4 of EudraLex by the European Commission. Good Manufacturing Practices are guidelines that provide a system of processes, procedures, and documentation to assure the product produced has the identity, strength, composition, quality, and purity that it is represented to possess.

 

Certification Process:

 

After the companies build and enhance their internal procedures and system, they call the governmental agency which is responsible for GMP certificate issuance. In Palestine, this is the Palestinian Ministry of Health and in the United States it is the Food and Drug Administration (FDA). Once the Ministry of Health receives the request, its GMP experts will inspect all aspects of the company to ensure standards compliance. Inspection will include ingredients used, drug validity, storing and packaging conditions, research and development, quality control, spaces and layout.

 

It is important to note that inspections are different from auditing, as inspections include demonstrations of some experiments to ensure compliance. GMP inspection is much more complicated than ISO9001 auditing, since GMP includes detailed technical requirements which need more complicated procedures than ISO9001.

 

According to the GMP inspection results, the company will or will not be GMP certified. If the company is not able to achieve the GMP requirements, the inspectors will give the company another chance to achieve the requirements and once it fulfills these requirements it will be GMP certified.

 

Costs:

 

GMP certification is managed by the Palestinian Ministry of Health and does not have any certification fees.

 

Benefits of the GMP:

 

The following points are GMP general benefits:


1. Increases the creditability and offers a competitive advantage in the marketplace for contract manufacturers


2. Increases senior management confidence in the preparedness of manufacturing facilities for inspection


3. Decreases the time and cost for companies selecting third-party testing and product certification if using GMP registered contract manufacturer;which is a national program that is designed to provide a system of processes, procedures, and documentation to ensure that the product produced has the identity, strength, composition, quality, and purity that it is represented to possess


4. Manufacturers of dietary supplements that comply with GMP requirements receive certificates and are listed on the NSF website (www.nsf.org)


5. Available to all manufacturers of dietary supplements.