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GMP

Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. WHO has established detailed guidelines for good manufacturing practice. Many countries have formulated their own requirements for GMP based on WHO GMP. Others have harmonized their requirements, for example in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention.

  • is GMP necessary if there is a quality control laboratory?

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    Yes. Good quality must be built in during the manufacturing process; it cannot be tested into the product afterwards. GMP prevents errors that cannot be eliminated through quality control of the finished product. Without GMP it is impossible to be sure that every unit of a medicine is of the same quality as the units of medicine tested in the laboratory

  • Costing of GMP: Can manufacturers afford to implement GMP?

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    Yes. Making poor quality products does not save money. In the long run, it is more expensive finding mistakes after they have been made than preventing them in the first place. GMP is designed to ensure that mistakes do not occur. Implementation of GMP is an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals. Making and distributing poor quality medicines leads to loss of credibility for everyone: both public and private health care and the manufacturer.

  • AS9100 - Quality Management System for Aerospace

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    AS9100 is the Quality Systems Aerospace Model for Quality Assurance in Design, Development, Production, Installation and Servicing.

    The International Aerospace industry realized the necessity to supplement the quality system model to satisfy internal, government, and regulatory requirements applicable to the aerospace industry that ISO 9000, as a generic standard, was never designed to satisfy.

    The AS9100 Certification was introduced in 1997 by the International Aerospace Quality Group (IAQG) to encourage International quality, safety and technology standards in air transport. The certification can be applied to all areas in aviation like design and manufacture of equipment, airport and airline operations, aircraft accessory supply, spares supply and maintenance. The AS9100 Certification enables an organization to demonstrate its commitment to quality, safety and reliability.

    The purpose of AS9100 Standard is to:

    - Standardize Aerospace quality expectations on a global level
    - Achieve improvements in quality and reduce costs
    - Add provisions for regulatory requirements
    - Capture aerospace supplements agreed to at an international level

    Benefits of AS 9100 certification:
    - Reinforces competitiveness
    - Helps maintain and improve market position
    - Increases your customers‘ trust in you as a safe supplier of products and services
    - Registration in the global database of certified aerospace suppliers OASIS (Online Aerospace Supplier Information System)

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