GXP Inspection & Lab Accreditation
【Update Date:2018-10-18】unit:品質監督管理組
GMP Development and Management for Western Pharmaceutical Manufacturers
In order to ensure manufacturing quality of medicinal products and to prevent possible cross-contamination and misuse of improper materials during the manufacture of medicinal products, the US was the first to announce its Good Manufacturing Practice (GMP) of medicinal products in 1963. Later, the World Health Organization (WHO) also announced its own GMP in 1969. The UK established the first version of GMP in 1971, Japan also formulated GMP in 1974, in accordance with the WHO version. Our central competent health authority promulgated Good Manufacturing Practice in 1982 and officially started to promote implementing GMP for western pharmaceutical manufacturers at the same time.
Implementation Process and Current Status of GMP for Domestic Western Pharmaceutical Manufacturers
I. Implementation of GMP (1977 through 1988)
In October 1977, the Department of Health (DOH) sent representatives to Japan to understand how GMP was implemented in western pharmaceutical manufacturers and began planning to implement GMP. At that time, there were around 700 to 800-plus such manufacturers in Taiwan. On January 13, 1982, the Ministry of Economic Affairs and the DOH officially formed the cross-ministerial GMP Joint Promotion Group; they jointly announced the Good Manufacturing Practice on May 26 of the same year. It was announced that pharmaceutical plants were to enforce the GMP, and the GMP Joint Promotion Group was responsible for providing assistance during the implementation process. At that time, there were a total of approximately 550 manufacturers in Taiwan.
In order to ensure continuous consolidation of the GMP system formedicinal products, in October 1987, the DOH started to systematize the implementation of the follow-up inspection and management program for GMP manufacturers. The Bureau of Food and Drug Analysis (now the Food and Drug Administration, TFDA) has been responsible for planning and conducting the program since April 1990. During this period, the number of domestic pharmaceutical manufacturers decreased to 200-plus.
II. Implementation of cGMP Validation (1995 through 2005)
Manufacturing processes of sterile preparations are to be planned and enforced in accordance with the most rigid standards. The DOH announced on April 29, 1995 the implementation of validation for sterile preparations; in order to enhance quality of medicinal products used by our citizens and to expand medicinal product exportation, the Good Manufacturing Practice and the Implementation Schedule for Medicinal Product Pharmaceutical Validation Processes were announced in May 1999, and were to be fully enforced in three stages across within five-years. Validation was promoted across the board by 2005. A total of 163 domestic manufacturers fulfilled the cGMP requirements.
III. Implementation of International GMP Standards (since 2007)
As technology advances, markets globalize, and increasing demands regarding the safety and quality of medicinal products by consumers, adoption of international GMP standards has become a trend among pharmaceutical industries around the world. Following promotion of GMP implementation and cGMP validations for medicinal products, the DOH went on to plan the implementation of international GMP standards in 2004. The DOH officially announced the Guide to Good Manufacturing Practice for Medicinal Products (PIC/S GMP) on December 19, 2007. Medicinal products manufactured quality in Taiwan is from quality control, quality assurance to risk management-based, and thus took a further step toward connecting with international standards. By December 31, 2014, complete across-the-board enforcement was in place. At present, there are a total of 137 PIC/S GMP-compliant pharmaceutical manufacturers in Taiwan.
IV. Domestic API Manufacturers
When the GMP system was enforced in 1982 for medicinal products, only pharmaceutical manufacturers of chemical preparations were asked to implement GMP. For API manufacturers, implementation of GMP was not compulsory. However, they were encouraged to do so in a phase-by-phase way. Some API manufacturers applied for GMP assessment and inspections with the DOH because their products were sold overseas and a GMP certificate was required.
In April 2002, the DOH announced the “Good Manufacturing Practice - API Operational Guide”, in accordance with ICH-Q7A, for the pharmaceutical industry’s reference and compliance. The Ministry of Health and Welfare (MOHW) in May 2013 updated the above-mentioned API operational guide, in accordance with the GMP Guide (Part II) announced by the PIC/S group, and changed its name to “Guide to Good Manufacturing Practice for Medicinal products (Part II :APIs)”. In order to allow the pharmaceutical industry understand the requirements sufficiently, related provisions were announced in both Chinese and English versions. These will continue to be updated in accordance with the latest GMP Guide announced by the PIC/S in the future. In addition, for the sake of consolidating source management for manufacturing quality, the MOHW announced in September 2013 that for APIs with an existing drug permits licenses should be meets the GMP requirements by December 31, 2015. This marked a new milestone for pharmaceutical quality management in Taiwan.