Pharmaceutical Firms Match New Regulatory Guidelines for Process Validation by bethjames


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									Compliance Insight, Inc.


          Pharmaceutical Firms Match New Regulatory Guidelines for Process Validation

(Fairfield, Ohio) Compliance Insight Inc. reports that the new guidelines on process validation in
Current Goods Manufacturing Processes (cGMP) issued by the US Food and Drug Administration
(FDA) are expected to result in stricter process and quality controls.

Results will also include broad-based adoption of PAT (process analytical technologies) that include
three key tools - tools, multivariate data acquisition and analysis, process analyzers, and process
controls. Additionally, there will be a focus on public safety and an increase in collaborations,
alliances and consolidation within the industry.

The best ways pharmaceutical firms can match the new FDA guidelines, according to Michael R.
Goodman, compliance specialist, Compliance Insight, is by implementing modern concepts in
pharmaceutical development like the Quality-by-design validation process. Ensuring quality risk
management at all levels is also recommended, along with ensuring quality systems at all stages of
the manufacturing process life cycle. For example, designing process validation, qualifying
equipment, and performing an initial process validation is crucial. These steps should be taken at
the very start of the first phase of a clinical trial.

Pharmaceutical firms must also define operating range by adopting a parameter and range
assessment research study. The aims of this study would be to define the acceptable range, defining
the critical steps, and separating critical crucial to successful scale-up. Transparency in research
would reduce need for tech-transfer verification at collaborator or contract-manufacturing level.
Pharmaceutical firms are recommended to take up the fragmented, life-cycle approach to process

The FDA recommends that pharmaceutical manufacturing companies take up risk-based analysis of
each piece of equipment and facility to increase the certainty of the process and analytical results,
according to Goodman. This can be done according to the following guidelines:
·Check on whether normal operations have direct impact on quality
·Equipment tolerance factors
·Check on interaction between in-process material, the systems material, and the material of which
the equipment is made

The goal should be to choose equipment that offers maximum accuracy and efficiency.

It is recommended that pharmaceutical firms complete at least three consecutive batches for
validation. Emphasis should be on avoiding cross-contamination possibly by dedicating one
production line to one single product though most companies would not be able to do so. Instead,
they should set some acceptable health-based limits on carryover from one production line to
another. These limits can be set for pharmacological and toxicological data on the last product or
cleaning agent used. Also, pharmaceutical firms must monitor and regulate dependence upon
CMOs – contract-manufacturing companies – which has been on the increase. Strict audit of CMOs
is recommended.

Compliance Insight, Inc. specializes in Regulatory and Quality Assurance consulting and training for
pharmaceutical, nutraceutical, medical device, chemical, and bio-technology companies in North
America, Europe and Asia.

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