1. GMP Introduction
The GMP are guidelines which are intended to provide guidance regarding
Good Manufacturing Practice (GMP) for the manufacture of active
substances under an appropriate system for managing quality.
These guidelines apply to the manufacture of active substances for
medicinal products for both and veterinary use. These guidelines could
be use for cosmetics manufacture.
2. Quality Management
One of the more important principles:
- Quality should be the responsibility of all persons involved in manufacturing.
Quality unit(s) should be independent of production and that fulfills both Quality Assurance (QA) and Quality Control (QC) responsibilities.
Quality Risk Management
Quality risk management is a systematic process for the assessment, control, communication and review of risk to the quality of the active substance. It can be applied both proactively and retrospectively. (PCDA Plan_Check_Do_Act)
The quality risk management system should ensure that:
- the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient (customer) through communication with the user of the active substance.
- the level of effort, formality and documentation of the quality risk management process is commensurate with the level risk
Examples of the processes and applications can be found in http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/2008_02_12_gmp_annex20_en.pdf
Internal Audits (Self Inspection) and Product Quality Review
In order to verify compliance with the principles of GMP for API's, regular internal audits should be performed in accordance with an approved schedule.
Regular quality reviews of Active Pharmaceutical Ingredients (APIs) or Active Substance should be conducted with the objective of verifying the consistency of the process.
Audit findings and corrective actions should be documented and brought to the attention of responsible management of the firm. Agreed corrective actions should be completed in a timely and effective manner. (continuous improvements).
3. Personnel
Personnel qualified by appropriate education, training and/or experience to perform and supervise the manufacture of intermediates and APIs. The responsibilities should be specified in writing. Continuous training should be periodically assessed.
Personnel should practice good sanitation and health habits.
Personnel should be avoid direct contact with intermediates or APIs.