Europharm Laboratoires Co., Ltd obtains GMP status and implements fully all the requirements of Hong Kong GMP Guidelines.



GMP is the abbreviation of " Good Manufacturing Practice". GMP is that part of quality assurance which ensures that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use. The rules of GMP aim at minimizing the risks, which are not only inherent in any pharmaceutical production, but also cannot be prevented completely through the testing of final products. There are basically two types of these risks, namely, cross-contamination and mix-ups caused by wrong labels being put on containers.

Good Manufacturing Practice (GMP) provides a standard of systemic production and quality management.

Under GMP:
1.

All manufacturing process are defined clearly, reviewed and proved to be able to manufacture pharmaceutical products of the required quality and complied with their specifications;

2.
 Critical steps of manufacturing processes and any significant changes made to the processes are validated;
3.

All necessary facilities or equipment are provided, including:
(a) qualified and trained personnel;
(b) adequate premises;
(c) suitable equipment;
(d) correct materials, containers and labels;
(e) approved procedures and instructions;
(f) appropriate storage and transport;
(g) adequate personnel, laboratories and equipment or in-process controls under the responsibility of the production management;
4.
 Instructions and procedures are clearly written for the facilities provided;
5.
 Operators are trained to carry out procedures;
6.
 Records are completed during manufacture to show that all the steps required by the defined procedures and instructions have actually done and the quantity and quality met the requirement; any significant deviations are fully recorded and investigated;
7.
 Records made during manufacture and distribution, which help trace the complete history of a batch, are retained in a comprehensible and accessible form;
8.
 The suitable storage and distribution of the products help minimize any risk to their quality;
9.
 A system is set up to recall any batch of product from sale or supply; and
10.
 Complaints about the marketed products are examined, the causes of quality defects investigated, and appropriate measures taken in respect of the defective products and to prevent recurrence.

In short, in order to minimize the risks of having mistakes, mix-ups and any contaminations during pharmaceutical product production, implementation of GMP is the only possible and reliable way. It can also be regarded as a feasible, scientific and systemic management policy inducing a constructive effect on production of pharmaceutical products.