GMP/GDP/GSP Certification



GMP for food industries :Good Manufacturing Practice has many interpretations but Codex Alimentarius guides us to know basic definition on.

GMP general Principles lay a firm foundation for ensuring food hygiene and should be used in conjunction with each specific code of hygienic practice, where appropriate, and the guidelines on microbiological criteria. The document follows the food chain from primary production through to final consumption, highlighting the key hygiene controls at each stage.

Design/Facilities are including: Location, Premises/Rooms, Equipment and Facilities.

Control of operation is including: Control of food hazards, Hygiene control system, Material requirements, packaging, water, supervision, recall system.

Maintenance/sanitation is including: Maintenance, cleaning, cleaning programs, pest control, waste management, monitoring system.

Personal Hygiene is including: Health status, illness, injuries, personal cleanliness personal behavior, visitors. Reference: codex Alimentarius For more information on GMP Training, Consult on factory design and Certification, please contact regional branches.

GMP for Drug Industries: Good Manufacturing Practices (GMP) are the part of quality assurance that ensures that drugs are consistently produced and controlled in such a way to meet the quality standards appropriate to their intended use, as required by the marketing authorization. Part of the Health Products and Food Branch Inspectorate (Inspectorate) program is to conduct inspections of establishments that are involved in activities covered by the Establishment Licensing framework. These inspections are conducted to verify the compliance with GMP (Part C, Division 2 of the Food and Drugs Regulations) which is a requirement for the issuance of an establishment licence. To ensure a uniform application of these requirements and help the industry to comply, the Inspectorate has developed the Good Manufacturing Practices Guidelines as well as a series of guides and other related documents.

GDP for Drug Industries: The Community pharmaceutical industry operates at a high level of quality assurance, achieving its pharmaceutical quality objectives by observing Good Manufacturing Practice to manufacture medicinal products which must then be authorised for marketing. This policy ensures that products released for distribution are of the appropriate quality.
This level of quality should be maintained throughout the distribution network so that authorised medicinal products are distributed to retail pharmacists and other persons entitled to sell medicinal products to the general public without any alteration of their properties.

GSP for Drug Industries: It is impossible to deny the importance and urgency of the pharmacotherapy in today’s medicine. There are 3 indicators of the service ability of the medical products: quality, efficiency and safety. But production of drugs according to these criteria does not guarantee the quality, efficiency and safety conservation for a point of delivery to the last target – the consumer. That is why during the distribution it is necessary to follow the requirements for each product very strictly. Today the most important international document, which sets these requirements, is “Good Storage Practice”(GSP).
The objective of this guide is to supplement the above-mentioned documents by describing the special measures considered appropriate for the storage and transportation of pharmaceuticals. However, they
may be adapted to meet individual needs where necessary, provided that the desired standards of quality are still achieved.
The guidelines are applicable not only to manufacturers of medicinal products but also to pharmaceutical importers, contractors and wholesalers, and community and hospital pharmacies. They should be adjusted in line with the type of activity where the storage of pharmaceuticals is taking place. National or regional regulations should be followed for all related activities.

GMP for Cosmetics Industries:Guidelines (ISO 22716)

These guidelines are intended to provide guidance regarding Good Manufacturing Practices for cosmetic products.
These guidelines have been prepared for consideration by the cosmetic industry and take into account the specific needs of this sector. These guidelines offer organizational and practical advice on the management of the human, technical and administrative factors affecting product quality.
These guidelines have been written to allow them to be used following the flow of products from receipt to shipment. Additionally, in order to clarify the way this document reaches its objectives, a principle is added to each major section.
Good Manufacturing Practices constitute the practical development of the quality assurance concept through the description of the plant activities that are based on sound scientific judgment and risk assessments. The objective of these GMP guidelines is to define the activities that enable you to obtain a product that meets
defined characteristics.
Documentation is an integral part of Good Manufacturing Practices.

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