Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials. Good manufacturing practices and inspection, Volume 2
Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel.
Many of the relevant documents endorsed by the Committee are reproduced in this volume providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control and in the pharmaceutical industry. This is the second updated edition of the compendium and includes texts published in 2005 and 2006 in the WHO Technical Report Series.
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Quality Assurance of Pharmaceuticals: A Compendium of Guidelines ..., Volume 1
World Health Organization
No preview available - 1997
accordance active pharmaceutical ingredients airﬂow analytical and/or Annex applicable appropriate approved aseptic audit batch number biological bulk calibration certiﬁcate chemical classiﬁcation clean area Committee on Speciﬁcations containers cross-contamination deﬁned designed documented dosage form drug regulatory authority ensure equipment established evaluation excipient Expert Committee facilities ﬁlters ﬁltration ﬁnal ﬁnished products ﬁrst ﬂow Geneva GMP inspectorate HACCP hazards HEPA herbal materials herbal medicines HVAC identiﬁed inspec inspection installation investigational products labelling laboratory maintenance manufacturing practices methods microbiological monitoring operational qualiﬁcation packaging materials parameters performance qualiﬁcation personnel Pharmaceutical Preparations pharmaceutical products premises pressure Product recalls programme puriﬁcation quality assurance quality control quality system radiopharmaceutical records reﬂects relevant responsible Return air sampling sanitization self-inspection signiﬁcant SOPs Speciﬁcations for Pharmaceutical standards starting materials sterilization sufﬁcient suitable Technical Report Series temperature testing tion Validation protocol veriﬁcation World Health Organization
Page 15 - Quality Assurance. All those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality.
Page 299 - Quality systems - model for quality assurance in final inspection and test.
Page 192 - If documentation is handled by electronic data processing methods, only authorized persons should be able to enter or modify data in the computer and there should be a record of changes and deletions; access should be restricted by passwords or other means and the result of entry of critical data should be independently checked.
Page 10 - Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals.
Page 183 - The qualification should follow the validation convention of design review or design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).
Page 17 - Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation or product specification.
Page 214 - Such samples shall be representative and properly identified. (4) The calibration of instruments, apparatus, gauges, and recording devices at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision, and provisions for remedial action in the event accuracy and/or precision limits are not met. Instruments, apparatus, gauges, and recording devices not meeting established specifications shall not be used. ˇ211.165...
Page 10 - WHO certification scheme on the quality of pharmaceutical products moving in international commerce.
Page 56 - ... master production and control records) or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed. The investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and followup.