Transcription of General guidance on hold‑time studies
{{id}} {{{paragraph}}}
Example: bankruptcy
General guidance on hold‑time studies
87 Annex 4 General guidance on hold time studies1. Introduction and background 882. Glossary 883. Scope 884. Aspects to be considered 89 Reference 9388 WHO Technical Report Series No. 992, 2015 WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-ninth report1. Introduction and backgroundManufacturers should ensure that the products that they manufacture are safe, effective and of the quality required for their intended use. Systems should be in place to ensure that pharmaceutical products are produced according to validated processes and to defined procedures.
Annex 4 89 prescribe a process for establishing hold times, but reflects aspects that should be considered in the design of the hold‑time study.
Loading..
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document:
Related search queries
Scale-up of Tablet Manufacturing, Draft Guidelines for Manufacturing Homeopathic, Guidelines for Manufacturing Homeopathic Medicines, Production Scale Blenders Blending Systems, Pharmaceutical Manufacturing- Health Safety 2, Manufacturing, Effects of Crospovidone and Croscarmellose, Tablet, Regulatory Expectations of Presentation of