Basic Principles of GMP:
Basic principle of GMP is to ensure quality and efficacy of products. Many countries has implemented acts to mandatory follow o GMP procedures and have created their own GMP guidelines that are defined into acts and rules. Basic concepts of all of these guidelines remain same to ensure quality and efficacy of product and of safeguarding the health of the patient as well as producing good quality medicine.
Principals of Good Manufacturing Practice (GMP)” means that part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization or product specification. GMP is concerned with both production and quality control.
The basic principles of GMP are:
- All manufacturing processes are clearly defined, systematically reviewed in the light of experience and shown to be capable of consistently manufacturing medicinal products of the required
- quality and complying with their specifications;
- critical steps of manufacturing processes and significant changes to the process are validated;
- Appropriately qualified and trained personnel e.g. Manufacturing Chemist, Analytical Chemist, Supervisors etc;
- Adequate premises and space;
- Suitable equipment and services;
- Correct materials, containers and labels;
- Approved procedures and instructions;
- Suitable storage and transport;
- Instructions and procedures are written in an instructional form in clear and unambiguous language, specifically applicable to the facilities provided;
- Operators are trained to carry out procedures correctly;
- Records are made, manually or by recording instruments, during manufacture which demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the product was as expected. Any significant deviations are fully recorded and investigated;
- Records of manufacture including distribution which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form;
- The distribution (wholesaling) of the products minimizes any risk to their quality;
- A system is available to recall any batch of product, from sale or supply;
- Complaints about marketed products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products and to prevent re-occurrence.
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- Liquid dosage form manufacturing unit i.e syrup/suspension
- Parenteral dosage form manufacturing unit i.e. Injection
- Eye/Ear Manufacturing unit
- Aerosol, pumps, sprays and inhalers manufacturing units
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