A comprehensive GMP compliance program
Regis' Quality Assurance (QA) department leads the company wide GMP compliance program. QA personnel track all GMP production, from raw material receipt to final product release. Our QA team maintains, reviews, and approves supporting documentation including training records, SOPs, batch records, protocols and drug master files (DMFs).
At the conclusion of each GMP manufacturing process, the batch record is finalized and confirmed to include the following information: completed operating procedure, product Certificate of Analysis (COA) and associated analytical results, and analytical data from the testing of all associated raw materials. All original documentation is kept on file at Regis as a stand alone document and a copy is sent to the customer for their review and archival. The QA department conducts internal as well as external audits and is the primary liaison during customer audits and agency inspections.
Regis works with the professional consultants to assist with internal auditing as well as to provide training for all employees. Maintaining compliance is as important to us as it is to our customers.
Personnel and Training
Regis recognizes the importance of training for both the development and maintenance of an effective work force, as well as regulatory compliance.
Each new Regis employee undergoes training on safety, GMP, and Right-to-Know policies prior to learning their specific duties. Job related training is conducted as a documented four step process.
In addition to the Regis policy and job related training, employees are encourage to attend workshops and seminars related to their specific assignments to promote personal development.
- Introduction to and importance of GMP
- Concept of Total Quality
- Material flow and processing
- Record control and management
- Departmental contributions to GMP
- Introduction to general safety concepts
- Evacuation procedures
- Injury and incident procedures
- Personal protective equipment
- Identification of potential hazards
- References/sources for hazardous materials
- Material Safety Data Sheets
- Container identification
- Spill cleanup and notification procedures