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Anvisa Vs WHO guidelines
This document summarizes the ANVISA GMP guidelines for Brazil. It begins with an introduction noting that Brazil incorporates WHO pharmaceutical quality assurance guidelines into national legislation. The guidelines cover initial provisions, quality management, sterile products, computer information systems, and herbal medicines. For each section, the document compares the Brazilian guidelines to WHO guidelines, noting areas where Brazil has additional or stricter requirements. The conclusion states that in addition to generally applicable GMP stipulations, the Brazilian guidelines also address sterile products, biological and herbal products, water for pharmaceutical use, and qualification and validation.
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- 1. ANVISA GMP GUIDELINES SPECIFICATION PRESENTEDBY- 1)PRATIK ZADE 2)NAYAN JHA 3)MAHESH CHAINPURE
- 2.
- 3. INTRODUCTION: • Brazil isa member of World Health Organization. • It is obliged to incorporate the WHO pharmaceutical quality assurance guidelines into national health legislation system without major deviations. • The first Brazilian GMP guideline was published in 1995. • Latest edition derived from the 2003 edition of the basic WHO GMP guide: Main principles for pharmaceutical products - Quality management in the drug industry: philosophy and essential elements. • WHO - ‘should’ ANVISA - ‘must’
- 4. INITIALPROVISIONS • Definesthe scope and purpose of RDC 17/2010 • Minimum GMP requirements are establishment regarding manufacturing medicinal products in and outside Brazil. Methods not addressed in RDC 17/2010 resulting from technical progress or the specific requirement still going. • Medicinal products – REGISTERED AND PRODUCED ONLY BY MANUFACTURES DULY LICENSED AND AUTHORIZED. • Occupational health topics and environmental safety also addressed.
- 5. QUALITYMANAGEMENT WHO GMPguideline: the structure and its subdivision into a total of 17 chapters are identical. Regarding the subject matter presented in each chapter, it is, however, structured differently. The Brazilian guideline is written in the style of the legal document which it is: each Article focuses on a single determination which can be numerically referred to in inspection reports and subsequently enforced if required.
- 6. Starting and intermediatematerials out of specification must be investigated and actions according to the CAPA procedure must be taken. Authorized person Technically responsible person Qualified person Title II COMPLAINTS
- 7. STERILE PRODUCTS (TitlefollowsWHOdeterminationspublishedin2002,2010) • Two topics (isolator technology, blow/fill/seal technology) added in RDC 17/2010 Reproduced, without any change, from the 2008 edition of Annex 1 to the EU GMP guideline • Guidelines for terminally sterilized products, RDC 17/2010 is stricter than WHO. (NOT TAKEN FROM W.H.O) high risk operations must be performed in grade C conditions. Garments of persons working in grade A/B areas must be changed after each work session. no exceptions are foreseen unlike W.H.O
- 8. COMPUTER INFORMATIONSYSTEM (OriginalEUGMPguidanceestablishedinAnnex11asabase) •EXHAUSTIVE GUIDE PREPARED BY ANVISA IN CO-ORPORATION WITH PROFESSIONALS OF ISPE, FOR VALIDATION OF COMPUTERISED SYSTEM. ISPE: International Society of Pharmaceutical Engineers • The concepts of risk management and electronic signatures are not addressed in guideline.
- 9. HERBAL MEDICINE (W.H.Oguidelinepublishedin2006) •Guidelines regarding medicines of herbal origin only, , combination products with those of animal or mineral origin are not addressed. 1. PROPER QA SYSTEM INSTALLED 2. ADEQUATE CONTROL ON MATERIAL 3. VALIDATED METHOLOGY • Herbal raw material derivatives containing GMO must comply with the specific standards.
- 10. CONCLUSION This guidelinecomprises not only the generally applicable GMP stipulations, but also covers a number of additional topics such as- • sterile products • biological and herbal products • water for pharmaceutical use • qualification and validation
- 11. • SUBPART A - SUBPART B •Chapter 1 General Provisions • Chapter 2 General Quality System Requirements • Chapter 3 Quality Documents and Records • Chapter 4 Design Control & RMP • Chapter 5 Process and Production Controls • Chapter 6 Handling, Storage, Distribution and Traceability • Chapter 7 Corrective and Preventive Actions • Chapter 8 Installation and Servicing • Chapter 9 Statistical Techniques • CLAUSE1- CLAUSE 8
Editor's Notes
- #2 introduction of SUS, the Brazilian government became the biggest purchaser of medicines in the country. In order to assure security, efficiency and quality of the medicines sold through the SUS system as well as through all the other pharmacies, the implementation of GMP principles became inevitable.
- #4 GMP guidelines on related topics have also been published by ANVISA, e.g. for active pharmaceutical ingredients and for the preparation of individual prescriptions in healthcare pharmacies.
- #5 Methods not addressed in BPC 17/2010 resulting from technical progress or the specific requirements of given products are permitted to be adopted, provided they are validated and do not prejudice the quality of the product.
- #7 This function is re- quired by law for all industrial companies operating in Brazil. Title II requires complaints regarding falsified products and stolen cargo to be notified to the responsible health authorities.
- #8 WHO has since substituted them with a new edition published in 2010. After sterlisation of products VERY STRINGENT, NO EXPECTIONS GIVEN. GRADE C ------ cleanliness of their air, earlier versions (A to D) of Federal Standard 209-----Clean areas for carrying out less critical stages
- #10 WHO 2006 PRESENTLY IN FORCE.