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.

Read further in:

https://marketo.spartasystems.com/rs/spartasystems2/images/Whitepaper%20-%20Raising%20Quality%20Results%20on%20%20Supplier%20Audits%20Using%20EQMS%20for%20Pharmaceutical%20Companies.pdf

Are Funny People More Successful in Business? - Forbes article which can be applied to your career and to adding humor to your training sessions

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A good article which is useful for personal growth....

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).

References:

 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)

https://www.fda.gov/ora/compliance_ref/cpg/cpggenl/cpg130-300.html

Contact for further information:

Rosa Motta, CDER

rosa.motta@fda.hhs.gov

FDA addresses retention of Internal Audit Reports - Read FDA's response to a question regarding retention of Internal Audit Reports

A good presentation on

CONDUCTING AN EFFECTIVE MEETING.

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.