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GMP Guide
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Checklists
PAI protocol for API
189.– EUR
*
(appr. 284.- USD)
More than 40 pages in length, this self-explanatory PAI protocol for API guides you through the entire PAI preparation process. Similar to the PAI Protocol for DPs, it focuses solely on the specific circumstances of API producers. ... » all details
PAI protocol for drug products
199.– EUR
*
(appr. 299.- USD)
More than 40 pages in length, this self-explanatory PAI protocol for drug products guides you through the entire PAI preparation process. It was created to systematically identify the strengths, opportunities, weaknesses and threats associated with organisation, personnel, quality documents, facilities, utilities such as water systems, clean steam and ... » all details
21-CFR 820 Quality systems checklist
210.– EUR
*
(appr. 315.- USD)
This ready-to-use 21 CFR 820 quality audit questionnaire (audit by mail) has been created for the assessment of potential device suppliers that need to comply with the US FDA regulatory requirements set out in 21 CFR 820. The checklist will help you evaluate potential suppliers and cut costs and outlay. This 26-page checklist covers all sections of ... » all details
Computer system validation and maintenance checklist
Updated Version
185.– EUR
*
(appr. 278.- USD)
This checklist will enable you to systematically assess the strengths and weaknesses of a computerised system validation using a uniform approach. A scoring option is included which enables you to compare different systems and helps you to judge the compliance status of these systems. The checklist, which contains more than 80 questions, can be used ... » all details
* plus 19% tax for customers from germany
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