Supply chain integrity is necessary to a pharmaceutical company’s success. Formal contracts, quality agreements, and product and chemical purchase specifications alone never guarantee supply chain integrity. Astute pharmaceutical companies implement audit processes as an integral component of supply chain management. Audits foster a culture of agreement adherence among partner suppliers. The benefits to both the pharmaceutical company and partner suppliers are mutual and strengthen the professional relationship.
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Are Funny People More Successful in Business? - Forbes article which can be applied to your career and to adding humor to your training sessions
GMP and Quality, Responsibility, Integrity, and Accountability This article describes how to instill these important character traits into your people to assure commitment to GMP
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While many companies are scaling back production operations around the world, Roche has seen its logistics and packaging operations in Switzerland grow by about 500 employees in recent years. To keep up with the need for trained employees for the operation, Roche says it will invest $105 million to build a new training center there.
The plant in Kaiseraugst in northern Switzerland handles quality control and drug packaging, and it currently has about 1,600 workers, according to Reuters. It has grown by 30% in the last 5 years. An article from Bilanz says Roche has already invested about SFr400 million ($423 million) in the Swiss plant and that the facility is currently training about 300 people in 14 "careers" to keep up with demand.
The piece says the SFr100 million training center will be a 12,000-square-meter, 5-story facility including lab and classrooms. The company will start work on the new facility in September and expects to have it complete in October 2014, Reuters reported. "The need for education and training opportunities for our employees is increasing," Matthias Baltisberger, head of Roche Basel-Kaiseraugst said in a statement.
Source: FiercePharma Manufacturing
A Major Mistake That Managers Make - Article by Russ Ackoff, Ph.D.
Do the CGMP regulations permit the destruction of an internal quality assurance
audit report once the corrective action has been completed?
The CGMP regulations (21 CFR 210 and 211) for finished pharmaceutical manufacturing
do not specifically address the requirement to conduct, or to keep records of, internal
quality assurance audits. If the report in question were from a routine audit to verify that
the firm's quality system is operating as intended, then it would be acceptable if the firm
elected to discard the report once all corrections have been verified.
However, any documentation of corrective action as a result of such an audit would have
to be retained (see 211.180 and 211.188). For example, if a routine internal audit finds a
problem with a mixing step and the outcome is a change in mixing time, all affected
procedures, including the master production record, are to reflect the necessary changes,
and such records are subject to FDA inspection as usual. Any investigation into the
impact this problem had on related batches is to be retained and also made available for
inspection by FDA (see 211.192).
In addition, any reports of investigations or evaluations prepared in response to, for
example, a product complaint (211.198), vendor qualification (211.84), periodic review
of records and data (211.180(e)), and a failure investigation (211.192) are not internal
audits as discussed above. Such records are subject to FDA inspection and must be
retained for at least the time specified in the CGMP regulations (see 211.180).
Preamble to the Current Good Manufacturing Practice in Manufacturing,
Processing, Packing, or Holding regulations; Federal Register, September 29,
1978 (vol. 43, no. 190), page 45015, paragraph 4 https://www.fda.gov/cder/dmpq
21 CFR 211.84: Testing and approval/rejection of components, drug product
containers, and closures
21 CFR 211.180: General requirements
21 CFR 211.192: Production record review
21 CFR 211.198: Complaint files
Compliance Policy Guide Sec. 130-300, (7151.02)
Contact for further information:
Rosa Motta, CDER
FDA addresses retention of Internal Audit Reports - Read FDA's response to a question regarding retention of Internal Audit Reports
A good presentation on
Its very useful to understand the effectiveness of meeting and conducting meeting effectively....
Why is GMP so important - Answers from the FDA
Why is GMP so important? This question is answered by the FDA in an article on facts about cGMPs. The FDA gives the answers in a compact form in 6 paragraphs on two pages. Read more.