Question added by
Sayyed Azharhusain Amjadhusain Sayyed
, Senior Quality Assurance Specialist , AL AIN FARMS FOR LIVESTOCK PRODUCTION
Date Posted: 2013/08/04
by
Yara Mouti , Associate Partner and Projects Director , Agon Consult
The best effective way to implement a daily GMP audit is mainly by using walkthroughs checklist, you can design and implement a walkthrough form that is flexebil enough to assist you to write down any observation you see during your daily routine walkthroughs, and plan for a corrective action.
Although I think that the best way to implement a solid daily audit program is through the intensive training for QA personnel, on the distinguishing of the auditor eye observations and implementing an immediate CAPA.
The pharmaceutical industry of the European Union maintains high standards of quality assurance in the development, manufacture and control of medicinal products. A system of marketing authorisations ensures that all medicinal products are assessed by a competent authority to ensure compliance with contemporary requirements of safety, quality and efficacy. A system of manufacturing authorisations ensures that all products authorised on the European market are manufactured only by authorised manufacturers, whose activities are regularly inspected by the competent authorities. Manufacturing authorisations are required by all pharmaceutical manufacturers in the European Community whether the products are sold within or outside of the Community.
Two directives laying down principles and guidelines of good manufacturing practice (GMP) for medicinal products were adopted by the Commission. Directive2003/94/EC applies to medicinal products for human use and Directive91/412/EEC for veterinary use. Detailed guidelines in accordance with those principles are published in the Guide to Good Manufacturing Practice, which will be used in assessing applications for manufacturing authorisations and as a basis for inspection of manufacturers of medicinal products.
The principles of GMP and the detailed guidelines are applicable to all operations which require the authorisation referred to in Article40 of Directive2001/83/EC and in Article44 of Directive2001/82/EC, as amended by Directives2004/27/EC and2004/28/EC, respectively. They are also relevant for all other large scale pharmaceutical manufacturing processes, such as that undertaken in hospitals, and for the preparation of products for use in clinical trials.
All Member States and the industry agreed that the GMP requirements applicable to the manufacture of veterinary medicinal products are the same as those applicable to the manufacture of medicinal products for human use. Certain detailed adjustments to the GMP guidelines are set out in two annexes specific to veterinary medicinal products and to immunological veterinary medicinal products.
The Guide is presented in two parts of basic requirements and specific annexes. Part I covers GMP principles for the manufacture of medicinal products. Part II covers GMP for active substances used as starting materials.
Chapters of Part I on “basic requirements” are headed by principles as defined in Directives2003/94/EC and91/412/EEC. Chapter1 on Quality Management outlines the fundamental concept of quality assurance as applied to the manufacture of medicinal products. Thereafter, each chapter has a principle outlining the quality assurance objectives of that chapter and a text which provides sufficient detail for manufacturers to be made aware of the essential matters to be considered when implementing the principle.
Part II was newly established on the basis of a guideline developed on the level of ICH and published as ICH Q7a on “active pharmaceutical ingredients”, which was implemented as GMP Annex18 for voluntary application in2001. According to the revised Article47 and Article51, respectively, of the Directive2001/83/EC and Directive2001/82/EC, as amended, detailed guidelines on the principles of GMP for active substances used as starting materials shall be adopted and published by the Commission. The former Annex18 has been replaced by the new Part II of the GMP Guide, which has an extended application both for the human and the veterinary sector.
In addition to the general matters of Good Manufacturing Practice outlined in Parts I and II, a series of annexes providing detail about specific areas of activity is included. For some manufacturing processes, different annexes will apply simultaneously (e.g. annex on sterile preparations and on radiopharmaceuticals and/or on biological medicinal products).
A glossary of some terms used in the Guide has been incorporated after the annexes.
The Guide is not intended to cover security aspects for the personnel engaged in manufacture. This may be particularly important in the manufacture of certain medicinal products such as highly active, biological and radioactive medicinal products. However, those aspects are governed by other provisions of Community or national law.
Throughout the Guide it is assumed that the requirements of the Marketing Authorisation relating to the safety, quality and efficacy of the products are systematically incorporated into all the manufacturing, control and release for sale arrangements of the holder of the Manufacturing Authorisation.
The manufacture of medicinal products has for many years taken place in accordance with guidelines for Good Manufacturing Practice and the manufacture of medicinal products is not governed by CEN/ISO standards. Harmonised standards as adopted by the European standardisation organisations CEN/ISO may be used at industry’s discretion as a tool for implementing a quality system in the pharmaceutical sector. The CEN/ISO standards have been considered but the terminology of these standards has not been implemented in this third edition of the Guide.
It is recognised that there are acceptable methods, other than those described in the Guide, which are capable of achieving the principles of Quality Assurance. The Guide is not intended to place any restraint upon the development of any new concepts or new technologies which have been validated and which provide a level of Quality Assurance at least equivalent to those set out in this Guide. It will be regularly revised.