How Do GMPs of Different Countries Compare?

At a high level, GMPs of various nations are very similar; most require things like:

• Equipment and facilities being properly designed, maintained, and cleaned
• Standard Operating Procedures (SOPs) be written and approved
• An independent Quality unit (like Quality Control and/or Quality Assurance)
• Well trained personnel and management

For example, here are the requirements for training from three different sets of drug GMPs.

  U.S.

• Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. [211.25(a)]

• Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess. [211.25(b)]

  Canada

• All personnel are aware of the principles of GMP that affect them, and all personnel receive initial and continuing training relevant to their job responsibilities. [C.02.006, interpretation 5]

• 5.1 Training is provided by qualified personnel having regard to the function and in accordance with a written program for all personnel involved in the fabrication of a drug, including technical, maintenance, and cleaning personnel.

• 5.2 The effectiveness of continuing training is periodically assessed.

• 5.3 Training is provided prior to implementation of new or revised SOPs.

• 5.4 Records of training are maintained.

• 5.5 Personnel working in areas where highly active, toxic, infectious, or sensitizing materials are handled are given specific training.

• 5.6 The performance of all personnel is periodically reviewed.

  European Union

• The manufacturer should provide training for all the personnel whose duties take them into production areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product. [EU # 2.8]

• Besides the basic training on the theory and practice of Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept.  [EU # 2.9]

• Personnel working in areas where contamination is a hazard, e.g. clean areas or areas where highly active, toxic, infectious or sensitising materials are handled, should be given specific training. [EU # 2.10]

• Visitors or untrained personnel should, preferably, not be taken into the production and quality control areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised. [EU # 2.11]

• The concept of Quality Assurance and all the measures capable of improving its understanding and implementation should be fully discussed during the training sessions. [EU # 2.12]

For other topics, there can be differences as to what regulatory bodies require or expect. For example, in the drug GMPs, the Canadians and European Union  require that internal quality audits be conducted, however that is not a written in the U.S. cGMPs. (In the U.S., quality audits are, however, an unwritten expectation of a well-functioning quality unit.) Another difference is that in Europe and Canada, "critical" processes and systems are validated; in the U.S., the FDA requires validation for virtually everything related to drug product production.