Technical Requirements for Pharmaceuticals. Experience with submissions of dossiers

Transcription

1 Technical Requirements for Pharmaceuticals. Experience with submissions of dossiers Henrik K.Nielsen Technical Specialist Essential Medicines Unit - Medicines and Nutrition Centre UNICEF SUPPLIER MEETING SEPTEMBER 2010 UNICEF SUPPLY DIVISION - COPENHAGEN, DENMARK

2 UNICEF SD Product evaluation is a key tool to ensure product quality UNICEF SD Technical Requirements for Pharmaceutical products The Interagency Pharmaceutical Product questionnaire

3 UNICEF SD UNICEF SD Technical Requirements for Pharmaceutical products Accompanies every tender for pharmaceutical products nical_requirements_for_pharmaceutical_produc ts_-_3rd_edition_-_april_2010.pdf

4 UNICEF SD

5 Specifications Specifications are reviewed and if necessary updated in connection with every Tender. Eg Nystatin oral suspension General Description: Nystatin oral suspension IU/ml, bottle of 30 ml. Technical Specifications: The oral suspension should contain IU/ml Nystatin complying with one of the pharmacopeias: BP Ph. Eur Ph. Int USP

6 Specifications Nystatin oral suspension, continued The oral suspension should comply with one of the pharmacopeias: Nystatin Oral Suspension BP, general monograph for oral liquids and general notices Ph.Eur. general monograph for liquids preparations for oral use and general notices Ph.Int. general monograph for liquid preparations for oral use and general notices Nystatin Oral Suspension USP and general notices and requirements

7 Specifications Packaging and Labelling: As per UNICEF Technical Requirements. Each dose is to be administered by means of a device suitable for measuring the prescribed volume (usually a syringe graduated by the measurement of 0.1ml). The measuring device should be enclosed with or attached to each bottle.

8 Technical Requirements for Pharmaceutical products Complete Pharmaceutical Questionnaire for Manufacturers Complete Interagency Agency Pharmaceutical Questionnaire Full International Non-proprietary Name (INN name)/no brand or trade name WHO-GMP Certificate Manufacturing license in country of origin Marketing Authorisation in country of origin, and exporting countries if applicable Certificate of Pharmaceutical Product (CPP) API, References to Pharmacopeias and CEP/DMF

9 Technical Requirements for Pharmaceutical products Specifications for Finished Pharmaceutical Products (reference: International Pharmacopeia, European Pharmacopeia/British Pharmacopeia or United States Pharmacopeia) and monographs where applicable CoA s of 3 production batches Stability studies of the Finished Pharmaceutical Product Language requirements: English and French unless other specified Expiry date format: dd/mm/yyyy

10 UNICEF SD The Interagency Pharmaceutical Product questionnaire

11 Interagency Pharmaceutical Product questionnaire Standardised technical evaluations of pharmaceutical products Reduced workload for both the bidder and agencies Considered as the basic minimum Currently part of the WHO Model QA system for procurement agencies

12 Challenges: Incomplete filled in questionnaire Inadequate information In general follow up via s

13 Challenges: Notification about changes: Finished product specifications Container closure systems Stability testing methodologies, API source, routes of synthesis and/or specifications of API, GMP status, manufacturing processes, contract manufacture if any and manufacturing site.

14 Challenges, Experiences: Samples (Fit-for-purpose/usability) e.g.: Appropriate sealing of primary container. Large Volume Parenterals w.giving set Injectables together w. specific diluents Number of samples and in case of changes resubmission of new samples Break marks solid tablets Oral liquids with dose measuring devices

15 Challenges: Many companies include the Essential Medicines logo in the packaging materials. Please note the logo is a property of WHO.

16 Challenges: Stability studies should be conducted in the final packaging reflecting real time and accelerated stability studies as per WHO/ICH Guidelines In stability report numerical results should be stated instead of conforms/complies The proposed shelf-life must be supported by the stability studies submitted Storage conditions should be based on and reflect stability studies

17 Challenges: Example: Store in a cool place protected from light Do not store above 25 C protected from light PLEASE for the future Perform stability realtime studies Zone IV a 30 C/ 65 RH Zone IV b 30 C/ 75 RH

18 Thank You