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.

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 established for each process that affect the quality of the finished product. Systems are laid 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 as WHOcGMP. 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.

According to the Control of Drugs and Medications Regulations 1984 (CDCR 1984), the term ‘manufacturing’ is defined as:

a) The making or assembling of the product;

b) The enclosing or packing of the product in any container in a form suitable for administration or application, and the labelling of the container, and;

c) The carrying out of any process in the course of any of the foregoing activities.

GMP compliance is one of the requirements for product registration and/ or notification of medications, as well as to apply for a Manufacturer’s Licence with the Drug Control Authority (DCA).

Uncontrolled manufacturing operations may be detrimental to consumer health and safety. GMP status attained gives assurance that the product manufactured is safe, efficacious and of quality and thus gaining consumer confidence.

Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers.

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.

A poor-quality medicine may contain toxic substances that have been unintentionally added.

A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect.

An inspection upon every manufacturer of registered medications is required based on the requirements of certain guidelines.

-GMP / GDP Guidelines Product Type / Category

-PIC/S Guide to Good Manufacturing Practice for Medicinal Products

-Pharmaceuticals (Poison and Non-Poison)

-Veterinary Products

-Guidelines on GMP for Traditional Medicines & Health Supplements, 1st Edition, 2008.

-Traditional Products

-Health Supplements

-Veterinary Products (Premixes)

-For activities related to the storage and distribution by manufacturers, importers and wholesalers (where applicable)

There are a few types of GMP inspection:

- Initial Inspection: An inspection conducted on new medications manufacturer that have not notified any medications.

- Pre-licensing: An inspection conducted on new manufacturers as a pre-requisite to register products and for applying Manufacturer’s Licence.

- Pre-approval: An inspection conducted on new production line of licensed manufacturers.

- Pre-certification: An inspection conducted on premises that are not regulated by Drug Control Authority.

- Verification: An inspection conducted following a punitive action. Depending on the condition, verification inspection can be combined with routine inspection.

GMP compliance is rated as Acceptable or Unacceptable. The level of compliance is determined by the weaknesses/ non-conformances found during an inspection.

In general, all manufacturers of registered products/ notified medications will be inspected routinely. The frequency for inspection is determined according to the risk level of the product manufactured, as well as the latest GMP compliance rating.

For pharmaceutical manufacturers, inspections will be scheduled according to the Risk Based Inspection Planning module, which takes into account aspects such as site complexity, process complexity, product complexity, number of deficiencies from the recent inspection, any changes to the site after the previous inspection, product complaints and/ or regulatory actions received.

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.

Prior to an inspection, an officer is appointed as the lead inspector and will determine the date of inspection, as well as a proposed inspection plan. Each inspection is led by a lead inspector and may be joined by other inspectors. The number of inspectors required is based on the size of the facility, type of product manufactured and inspection scope.

- An inspection is preceded by an Opening Meeting, during which the objective, related guidelines, scope and inspection areas will be explained.

- After the Opening Meeting, the inspection of the manufacturing premises, store premises, laboratory and documentation system shall commence.

- At the end of the inspection, the lead inspector (and other accompanying inspectors) will present inspection findings during a Closing Meeting. The GMP compliance status will be determined during the Premises Inspection Evaluation Committee Meeting.

Generally, a Good Manufacturing Practice (GMP) Inspection Report will be issued after each inspection is conducted. The manufacturer is expected to provide feedback regarding corrective and preventive actions (CAPA) taken towards each reported finding within a stipulated timeframe.

Punitive actions can imposed on manufacturers and will be determined by the Premises Inspection Evaluation Committee Meeting.

Registered products manufacturers:

i) New product registration application will be rejected

ii) Product registration renewal will not be allowed

iii) Currently registered products will be suspended

Notified medications manufacturers:

i) New medication notification application will be rejected

ii) Renewal of medication notification will not be allowed