A guide for pharmaceutical firms applying new regulatory guideline to process validation.

1. HOW TO APPLY NEW REGULATORY
GUIDELINES TO
PHARMACEUTICAL PROCESS
VALIDATION

2. New Expectations
 FDA has new expectations related to process
validation through their release of Current Goods
Manufacturing Processes (cGMP) that include
 Process and quality controls that are more stringent
 Integration of PAT (process analytical technologies)
that utilize multivariate data acquisition and analysis,
process analyzers, and process controls
 Development of public safety programs
 Expansion of industry consolidations and
collaborations

3. Guidelines
 Compliance Insight specialist Michael Goodman
advises that the FDA guidelines can be met by
pharmaceutical companies implementing a plan
that focuses on
 Using Quality-by-Design validation process and other
modern approaches
 Applying risk management in each area of the company
 Integrating quality systems throughout the
manufacturing process

4. Clinical Trial
 Begin the first phase of a clinical trial by
focusing on specific elements
 qualifying equipment
 designing process validation
 performing an initial process validation

5. Research Studies
 Strategically choose research studies
 One defines the operating range by outlining a
parameter and range assessment research study
and critical steps to successfully scaling-up
 Transparency plays important role in research to
reduce tech-transfer verification at collaborator or
contract-manufacturing level
 Life-cycle approach to process validation is
recommended

6. Assessing Equipment
 Assess all equipment and facilities to maximize
process and analytical results says Goodman
 FDA recommends pharmaceutical
manufacturing adopt risk-based analysis to
accomplish this

7. Equipment and Facilities
 To succeed follow these guidelines
 Assess operations and how they influence quality
 Understand equipment tolerance factors
 Evaluate interaction between the systems
material, in-process material and the material of
which the equipment is made
 Choose equipment that offers the best in accuracy
and efficiency

8. Validation
 Pharmaceutical companies need to complete at
least three consecutive batches to determine
validation
 Eliminate cross-contamination
 Preferred that dedication of one production line
is to one single product
 Not feasible for most companies
 Determine acceptable health-based limits on
carryover
 Set limits for using pharmacological and toxicological
data on the last product or cleaning agent used

9. Important Issue
 Another important issue for pharmaceutical
firms is to strictly monitor and audit CMOs
(contract-manufacturing companies)

10. Compliance Experts
 Compliance Insight, Inc.
 Your Hands-On Quality and Regulatory Specialists
 Our services include GMP consulting, audit preparation, FDA
mock inspections, FDA response assistance, vendor/contract
audits, GMP training and accreditation, new construction
compliance, regulatory consulting, investigations, biosafety
and viral testing consulting; clinical trial audits and more.
 For more information visit http://compliance-insight1.com/