More than Just Lines on a Map: Best Practices for U.S Bike Routes
How to apply new regulatory guidelines to pharmaceutical
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/