GMP Standard («Good Manufacturing Practice») – the system of norms, rules and regulations regarding the production of pharmaceuticals and medical devices. In contrast to quality control procedure by studying the selective product samples, which provides the usability only these samples (and possible, the batches are made in the nearest future), standard GMP reflects a holistic approach, regulates and evaluates the characteristics of production and laboratory testing.
GMP includes quite large number of indicators, which must be met companies producing a particular product. GMP for pharmaceutical companies defines the parameters of each production stage - from material of which made the workshop floor, and the number of microorganisms per air cubic meter, to the clothing of staff and the labels on product packaging.
We started the conversion to GMP standards in 2002 and introduced it by the following areas:
- Teaching of company staff of principles and bases of GMP. The inner educational system was created at the company and all staff, which can affect on the quality on finished product, passes this teaching.
- Improvement our documentation’s system. The company has introduced and constantly improved document management system, which is regulated by the standard of GMP.
- Reconstruction of industrial premises and premises of analytic and microbiological services. The factory buys the best world samples of laboratory equipment.
- Realization of validation’s measures. All methodic of analytic trials, equipment, premises, production processes and cleaning pass certification (validation). In the drugs production are used only certified processes.
- Realization of inner audits (self-inspection). Such control makes possible to take timely and necessary steps to eliminate identified deficiencies.
- Work with the reclamation and discrepancies. All reclamation and information, relating the products with supposed quality violations, which is coming to the company, are registered and analyzed. None of reclamation, which is came to the company from patients and individuals don’t remain unanswered and necessary investigation.
Strict observance by staff of the most important elements of GMP conception let to keep our quality’s standards at the highest level and produce the effective preparations, which are helped people.