GMP Quality Assurance

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GMP Quality Assurance

Overview of GMP Quality System

Regulatory Inspections

J-STAR manufactures intermediates and APIs for use in clinical trials. J-STAR has not manufactured APIs for commercial drugs, so is not registered with the FDA and has not been inspected by the agency.

J-STAR has been audited by many clients for whom we have produced APIs for use in clinical trials.

Compliance Model

GMP operations at J-STAR Research are carried out in compliance with the Q7 guidance, as it pertains to APIs for use in clinical trials. The other guidances most relevant to GMP activities at J-STAR are ICH Q1(A,B,E), Q2(A,B), Q3(A,C), Q6A, and FDA’s CGMP for Phase 1 Investigational Drugs.

GMP Structure

The Quality Unit is independent of Production. It consists of Quality Assurance (Director of QA, two Associate Directors of QA, and QA Associate) and Quality Control/Analytical Development (Vice President, Analytical Development/Quality Control and 8 additional scientists). QC/AD is located in its own laboratory, separate from the Production and R&D laboratories.

Training Program

All personnel engaged in GMP operations are trained for their tasks. The training is documented and may cover general concepts or specific projects.

The training is conducted by Production, QC/AD, or QA as appropriate.

Documentation System

The functions of Production and the Quality Unit in GMP operations are described and controlled by Standard Operating Procedures, the distribution of which is also controlled.

The SOPs cover the activities typical of clinical API manufacture, including, but not limited to, personnel qualifications, material control, manufacturing controls, testing and release, equipment maintenance and qualification, change control and investigations.

Specific written procedures cover the use of equipment and test instruments, as well as the execution of manufacturing processes and the conduct of testing.

Regulated activities are documented in writing as they occur.

Equipment Qualification, Calibration and Cleaning

Equipment used for GMP manufacturing is calibrated and/or qualified on a regular schedule.

Equipment used for GMP manufacturing is verified clean between products. Product residue recoveries are validated.

Instruments and equipment used for GMP testing are calibrated and/or qualified on a regular schedule.

In both departments calibration and qualification activities may be conducted by outside contractors or by qualified in-house personnel.

All calibration, qualification and cleaning activities are documented in the respective department records and logbooks.

Analytical Method Qualification / Validation

Test methods developed in-house are demonstrated to be scientifically sound for their intended purposes, which can be documented in method development reports. This is consistent with early stage pre-clinical and clinical drug development and the current FDA guidance for GMP compliance for Phase 1 drugs and APIs.

Formal method qualification or validation applicable to any given phase of clinical development can be performed at the request of the client. Stability indication can be included if required for the method.

Capabilities

QA responsibilities include, but may not be limited to, the following activities related to GMP operations:

  • Oversight of SOP/controlled document/regulated record maintenance review update distribution and recall
  • Oversight of training program and maintenance of training records
  • Oversight of program and review of records for maintenance calibration and/or qualification of process and analytical equipment used in GMP activities
  • Review and approval of method and equipment validation/qualification protocols and reports
  • Review and approval of master batch records and specifications
  • Ensuring that change control is applied where needed
  • Ensuring that adequate deviation and OOS investigations are conducted in a timely manner and completed before product is released
  • Final review of batch process and analytical records and the release or rejection of GMP product or intermediate for distribution to clients
  • Liaison between clients and/or regulatory agencies and J-STAR staff for quality issues
  • Assisting coordination between Production and QC/Analytical Development with regard to timelines and client expectations and deliverables