Quality Assurance

Regis' Quality Assurance (QA) department leads the company wide CGMP compliance program. QA personnel track all CGMP 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 CGMP manufacturing process, the batch record is finalized and confirmed to include the following information: completed batch 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 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 clients.

Regis Technologies Quality Assurance Reviewing Data
A Comprehensive CGMP Compliance Program

Personnel 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, CGMP, 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 encouraged to attend workshops and seminars related to their specific assignments to promote personal development.

Training Outline

CGMP

  1. Introduction to and importance of CGMP
  2. Concept of Total Quality
  3. Material flow and processing
  4. Record control and management
  5. Departmental contributions to CGMP

Safety

  1. Introduction to general safety concepts
  2. Evacuation procedures
  3. Injury and incident procedures
  4. Personal protective equipment

OSHA Right-to-Know

  1. Identification of potential hazards
  2. References/sources for hazardous materials
  3. Material Safety Data Sheets
  4. Container identification
  5. Spill cleanup and notification procedures

Regis Technologies Quality Assurance Reviewing Data
A Comprehensive CGMP Compliance Program

Personnel 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, CGMP, 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 encouraged to attend workshops and seminars related to their specific assignments to promote personal development.

Training Outline

CGMP

  1. Introduction to and importance of CGMP
  2. Concept of Total Quality
  3. Material flow and processing
  4. Record control and management
  5. Departmental contributions to CGMP

Safety

  1. Introduction to general safety concepts
  2. Evacuation procedures
  3. Injury and incident procedures
  4. Personal protective equipment

OSHA Right-to-Know

  1. Identification of potential hazards
  2. References/sources for hazardous materials
  3. Material Safety Data Sheets
  4. Container identification
  5. Spill cleanup and notification procedures

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