|
|
What's New at GQA?
| 21 CFR 111 Compliance |
Pharmaceutical Compounding |
The FDA has issued the
final rule establishing regulations to require current good manufacturing
practices (CGMPs) for dietary supplements. These new regulations will require
that dietary supplement manufacturers put into place proper controls to insure
that dietary supplements are processed in a consistent manner and meet quality
standards. The final rule has been staggered over a three-year period based on
the size of the organization. The final CGMPs are effective June 2008 for large
companies, June 2009 for companies with less than 500 employees, and June 2010
for companies with less than 20 employees.
GQA can assist in the assessment and
development of quality systems to meet this new standard. Contact us to discuss
your specific needs.
|
USP<797> (Pharmaceutical Compounding -
Sterile Preparations) became effective in 2004. 460.200 - Pharmacy Compounding
Guidance was issued by FDA in 2002. The FDA has issued Warning Letters to
pharmacy compounding facilities in violation of requirements outlined in <797>
and 460.200, and FDA oversight of compounding facilities has increased. GQA can
provide expertise in auditing to meet these requirements as well as design and
develop procedures, systems, and facilities.
GQA has worked with several compounding pharmacies to
evaluate their compliance to USP <797> and the FDA guidance document. We have
the experience and background to help with developing and improving the systems
to ensure compliance. |
| FDA Emphasizing Supplier Controls
|
GQA Participation in the Mountain States PDA Golf Tournament |
In the wake of recent drug quality
incidents such as heparin contamination, the FDA is seriously considering how drug ingredient
supply chains need to be audited, according to staff from CDER’s Officer of Compliance.
Steve Wolfgang, a consumer safety officer with the Division of Manufacturing and Product Quality,
made the statement at the International Society for Pharmaceutical Engineering’s 2008 Engineering
Regulatory Compliance conference.
Noting the importance of using stronger supplier qualification programs and increasing the
frequency of vendor audits, Wolfgang said supplier agreements often focus more on ingredient
price and less on the ability to trace ingredients.
He emphasized the importance of drug makers’ audits of ingredient suppliers to ensure there are
no unknown GMP deficiencies. He also encouraged companies to pay attention to suppliers’ GMP
and good distribution practices.
Wolfgang said he could not say whether changes to regulations are under consideration when asked
if the FDA plans to require firms to audit their suppliers. He said current GMP rules are strong
and give the FDA the authority to focus on the ingredient supply chain.
|
|
David Mayorga with his foursome getting ready for the Mountain States PDA Golf
Tournament that was held June 6th at the Broadlands golf course in Broomfield,
Colorado. They didn't win.....
...but it was another beautiful day in Colorado. |
|
|
|
Risk Management
Risk management is a continual process of
optimizing a product's benefit/ risk balance throughout its lifecycle by:
-
Understanding its benefits and risks.
-
Devising interventions to minimize risks.
-
Evaluating interventions against newly
acquired knowledge.
-
Revising interventions when appropriate.
FDA has identified efficient risk management as the primary
way to make the most effective use of agency resources and address these
challenges. Efficient risk management requires using the best scientific data,
developing quality standards, and using efficient systems and practices that
provide clear and consistent decisions and communications for the American
public and regulated industry. The FDA has long led the way in the science of
risk management, and this ability is more important than ever, given the
expanding complexity of the agency's challenges and the need to reduce the
health risks facing the public at the lowest possible cost to society.
ICH Q9: Quality Risk Management
The ICH Q9 guideline provides principles and examples of tools of quality risk
management that can be applied to all aspects of pharmaceutical quality
including development, manufacturing, distribution,
and the inspection and submission/review processes
throughout the lifecycle of drug substances and drug
(medicinal) products, biological and biotechnological products, including
the use of raw materials, solvents, excipients, packaging and labeling materials.
|
