International GMPs

The GMPs

Most GMP codes are built around the need to have an effective Qquality Ssystem in place. The Canadian GMP Guidelines 2002, states in its introduction that GMP are concerned with both production and quality control and that a system of quality assurance appropriate for the manufacture of drugs should be in place to ensure that:

1. Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
2. Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
3. All necessary key elements for GMP are provided, including the following:
   - qualified and trained personnel
   - adequate premises and space
   - suitable equipment and services
   - correct materials, containers and labels
   - approved procedures and instructions
   - suitable storage and transport
4. Instructions and procedures are written in clear and unambiguous language.;
5. Operators are trained to carry out and document procedures.;
6. Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.;
7. Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.;
8. The distribution of the drugs minimizes any risk to their quality.;
9. A system is available for recalling any batch of drug from sale or supply.;
10. Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.

A comparison on the chapter headings of the key GMP codes illustrates how these principles have been incorporated into national, regional, and international GMPs, and most GMP codes cover all these principles as can be seen from the table below, showing where in the GMP codes the quality systems are referred.

( the √ symbol in the table indicates that the topic is discussed in the document, but that the section of the document where discussion occurs is either in an introduction, or other unnumbered section of the regulations.)

These GMP codes apply to all dosage forms equally, however it is recognized that some dosage forms provide unique challenges in the attainment of quality. Most countries either provide sections of the code, or annexes to their code, or supplemental guidelines, or even separate GMP codes covering the manufacture and testing of sterile products, active pharmaceutical ingredients (APIs), medicinal gases, biological products, vaccines, and blood products.

All the GMP codes equally apply to human and veterinary drugs; and since the 2004 inclusion of GMPs for Investigational Medicinal Products in the EU GMPs, all GMP codes also apply to pharmaceutical products for use in clinical trials.

The greatest differences between these GMP codes are in four areas:

1. the expectations of Quality Management and the role of the “Qualified Person”
2. the expectation for, and extensiveness of validation being performed
3. the need for self-inspection
4. the role of contract manufacture and analysis

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