Article archive

Dun and Bradstreet Verification in the EU Site Master File?

17/10/2013 00:39
With the binding mention of a Site Master File in revised Chapter 4 of the EU GMP Guide, the document has become obligatory for all pharmaceutical companies. Details regarding the content of such a Site Master File were published by the EU in Part III of the EU GMP Guide. Although Part III is not...

ASEAN Countries published Draft of a Guideline on Process Validation

17/10/2013 00:37
The member states of the Southeast Asian association (ASEAN) have released the draft of a process validation guideline under the management of Singapore. Members of the ASEAN countries are: Thailand, Singapore, Indonesia, Malaysia, Vietnam, the Philippines, Myanmar, Cambodia and Brunei. In a word,...

USP visual inspection expert answers for question regarding AQL testing

17/10/2013 00:35
Question: We carry out the visual inspection of lyophilisates (freeze-dried products in the following way: 100% visual inspection of each vial (Semiautomatic inspection as well as manual inspection depending on the line) AQL inspection is done in accordance to the ISO standard (315 or 500...

Revision of the USP Chapter on Packaging and Storage Requirements <659>

17/10/2013 00:31
In the Pharmacopeial Forum No 39(4), the USP has published a proposal for the revision of Chapter <659> on "Packaging and Storage Requirements". The revision particularly points out the "single-dose container" definition which means that a medicinal product is intended for one-time use in one...

Overview of the Requirements on WFI in the EU, USA and Japan

17/10/2013 00:22
Again and again, the question arises about the limits laid down in the different GMP regulations and Pharmacopoeias and what procedures are applicable to the manufacture of water for injection (WFI). The table below gives you an overview of the current requirements on the production as well as on...

Article on the consequences of non-compliance

17/10/2013 00:21
Wockhardt stock drops after UK regulator revokes GMP certificate Oct 2013 - Read this news article on the consequences of non-compliance

WHO publishes revised draft on GTDP for pharmaceutical starting material

17/10/2013 00:19
The WHO guide on Good trade and distribution practices for pharmaceutical starting materials was published in 2003. In 2006, the International Pharmaceutical Excipients Council (IPEC) – an industry association comprising excipient manufacturers, excipient distributors and their pharmaceutical...

FDA Launched Secure Supply Chain Pilot Program

17/10/2013 00:17
The U.S. Food and Drug Administration published a notice announcing the launch of the Secure Supply Chain Pilot Program (SSCPP), which will enable qualified firms to expedite the importation of active pharmaceutical ingredients and finished drug products into the United States. The goal of the...

EMA publishes revised dossier-submission requirements for active-substance master files

17/10/2013 00:15
The European Medicines Agency published the following press-release on 14. August 2013: "The EMA has updated its pre-authorisation procedural advice for users of the centralised procedure to reflect new requirements for the submission of active-substance-master-file (ASMF) dossiers as part of human...

1997 - 2003 - 2013: Quo vadis 21 CFR 11?

17/10/2013 00:13
After a couple of years hard working on a regulation regarding the use of electronic records and signatures for regulated activities, FDA released the rule 21 CFR 11 (also called "Part 11") entering into force on August 20th, 1997. In September 2003, after several years of "wandering", FDA provided...
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