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 Raw Materials, In-Process phases, Finished Dosage forms and representative packaging samples are all withdrawn according to PII SOPs and retained for future reference.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