Quality
Assurance and Regulatory Affairs
PII places great
emphasis on quality as this is the key to successful pharmaceutical
production.
PII’s Quality Assurance Department
is involved in all aspects of projects, from introduction
through technical document preparation to commercial launch.
Over 10 percent of our employees are in the Quality Assurance
Department.
QA is involved in the following areas:
Audits
PII has been inspected by the U.S. Food and Drug Administration
(last inspection in May 2004), the European Union and the
U.S. Drug Enforcement Administration. In addition, PII’s
Quality Assurance department routinely hosts customer audits
for compliance, environmental safety and security. On average,
PII is subject to approximately three audits per month and
employs individuals specifically for the attention this activity
warrants.
Sampling and Release of Materials
All materials received by PII undergo QA inspection, quarantine,
sampling and release. Materials entering PII are sampled in
a dedicated sampling location according to a statistical sampling
plan. These materials are held in quarantine until tested
by QC and formally released by QA.
Finished Product Release
The Quality Assurance Department provides oversight of the
manufacturing and packaging processes through its Operations
group - from manufacturing to batch record review and ultimately
the final release of the product.
Documentation
Quality Assurance is an integral part of PII’s documentation
process. Master Production Records, Master Packaging and Labeling
Records, Stability Protocols and all regulatory documents
are drafted, reviewed and approved either by or with QA input.
Completed documents are tracked, reviewed and retained by
the QA Document Control function.
Samples
In addition to client and process-stipulated samples, Quality
Assurance withdraws documentary retention samples of every
batch of product PII manufactures. Raw Materials, In-Process
phases, Finished Dosage forms and representative packaging
samples are all withdrawn according to PII SOPs and retained
for future reference. All samples are stored in controlled
environment locations for a minimum of 21CFR specified durations.
Cleaning of Equipment
QA is responsible for the release of all equipment and rooms
to manufacturing. PII develops and validates analytical cleaning
methods for all compounds manufactured at our facility. Equipment
cleaning procedures are developed for the compound from analytical
methods. Cleaning verification is performed on all equipment
after manufacturing while cleaning validation is performed
only on commercial product.
Vendor Qualification Program
Vendor qualification is coordinated by the QA department and
includes interaction with contract laboratories. Vendors are
qualified for their materials and supplies by survey, audit,
analytical analysis and evaluation.
Quality Engineering
The Quality Engineering function has responsibility for key
metrics and analysis for the company. The trending of client
audit responses and critical production parameters form an
instrumental part of a customized training program. Tracking
investigations, conducting annual reviews, trending attributes
and reporting these to the individual departments and the
company’s top management are just some of QE’s
routine activities.
Pharmaceutics
International, Inc.
10819 Gilroy Road, Hunt Valley, MD 21031
Phone: 410 584-0001 Fax: 410 584-0007
www.pharm-int.com
Mission Statement: To deliver a quality dosage form development
service which meets all of our customers’ needs in a
timely fashion
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