'Despite regulatory challenges, the multinational pharmaceutical companies are keeping up with the global quality standards and current good manufacturing practices
Food and Drug Administration, in two complaints filed on May 9 in federal court, is seeking permanent injunctions to stop two stem cell clinic chains from marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice
In the 16-page document, entitled, "Contract Manufacturing Arrangements for Drugs: Quality Agreements," FDA recommends that owners and contract manufacturers implement written quality agreements to define each party's manufacturing activities/ roles to ensure compliance with current good manufacturing practices
Among their topics are current good manufacturing practices
, legacy facility master planning, architectural design issues, facility utility systems, high-purity water, process engineering, continuous oral solid dose processing, sterile manufacturing facilities, codes and standards, containment technology, occupational health and safety, sustainability, quality assurance/quality control laboratories and related support spaces, and packaging and warehousing.
According to PPMA, the pharmaceutical industry was obliged to maintain Current Good Manufacturing Practices
(CGMP) which demanded huge expense.
The Department of Justice filed a complaint on July 31 alleging that three Wisconsin companies that manufacture dietary supplements were not complying with FDA's current good manufacturing practices
and were misbranding their products.
These should address Hazard Analysis & Critical Control Points (HACCP) procedures, Current Good Manufacturing Practices
(CGMP), quality assurance (QA), regulatory compliance and sanitation procedures.
"By requiring all of the brands we carry to verify their compliance to current Good Manufacturing Practices
," said Andy Greenawalt, CEO, "we reinforce our commitment to our customers as their preferred source of safe, trustworthy, and clinically effective products, while allowing the increasing number of brands that go beyond required quality processes to share their practices with our professional customers.
Current Good Manufacturing Practices
and Quality Control Procedures to Prevent Adulteration of Infant Formula
" It's important to note that many Indian firms understand current good manufacturing practices
( CGMPs) and use them.
An official said on Friday, that, the process was being initiated in compliance with the current Good Manufacturing Practices
(cGMP), adding that the concerned minister had already informed the Senate about the proposed committee comprising of World Health Organization (WHO) officials and an expert each from four provinces.
He then considers preservatives as active ingredients; non-traditional preservatives, fragrances, and "natural" preservatives; measuring water activity, Hazard Analysis Critical Control Point (HACCP), and Current Good Manufacturing Practices
; and chelating agents and antioxidants.