Department | Quality Management | Document no | QMS-070 | ||
Title | Responsibility of Authorized Person | ||||
Prepared by: | Date: | Supersedes: | |||
Checked by: | Date: | Date Issued: | |||
Approved by: | Date: | Review Date: | |||
Document Owner
Quality Assurance Manager
Affected Parties
Quality Assurance Management
Purpose
The purpose of this document is to describe the accreditation, accountabilities and responsibilities of an Authorised Person. (AP)
Definition
AP | Authorized Person |
Bulk production batch | A batch of product, of a size described in the Marketing Authorization, either ready for assembly into final containers or in individual containers ready for assembly into final packs. |
Finished product batch | A batch of product in its final pack for release to the market |
Related Documents
QMS-035 | Deviation Report System |
QMS-090 | Evaluation of Batch Documentation and Release for Sale |
EHS Statement
There is no EHS implication.
Procedure
1.1. The principles for certification by an authorized person and batch release outlined in the Code of Good Manufacturing Practice of regulatory agencies will apply.
1.2. The Authorized Person who is accredited to release products for sale (for some regulated industries) to designated markets is recognized by the Quality Assurance Manager as having:
a. Formal current GMP training
b. Formal qualifications in a relevant scientific discipline
c. Attention to detail
d. Completed the training assessment.
e. Is a member of the Quality Assurance Department
1.3. The Authorised Person who is accredited to release raw materials, components and printed material by the Laboratory Manager as having:
a. Formal current GMP training
b. Formal qualifications in a relevant scientific discipline
c. Attention to detail
d. Is a member of the Quality Assurance Department.
1.4. An Authorized Person ensures at the release of a product for supply/sale that:
1.4.1. Before a finished product batch or bulk production batch is released the overall manufacturing supply chain of a particular batch of product, regardless of how many sites are involved is understood;
1.4.2. Is aware of the sites involved and be assured of the existence of QA/GMP agreements for the different intermediates.
1.4.3. The Marketing Authorization Application and the Manufacturer’s Authorization requirements have been met for the batch concerned.
1.4.4. The principles and guidelines of good manufacturing practice as outlined in Code of Good Manufacturing Practice of regulatory agencies are followed.
1.4.5. The principal manufacturing and testing processes have been validated.
1.4.6. All the necessary checks and tests in the manufacturing records have been performed.
1.4.7. All the necessary microbiological evaluations (if any) and chemical tests have been performed and results accepted.
1.4.8. Before any product is released any planned changes or deviations in manufacturing or quality control have been investigated, tested and assessed in accordance with the Deviation Reporting System.
1.4.9. Trained line management endorse all necessary completed production and QC documentation.
1.4.10. Experience staffs perform appropriate audits, self inspection and spot checks.
1.4.11. All relevant factors have been considered including any observation not specifically associated with the batch under review.
1.4.12. The legal requirements regarding imported and exported products have been fully met.
1.4.13. The arrangements in the QA agreement with the suppling site are verified.
Summary of Changes
Version # | Revision History |
QMS-070 | New |