1.Objective :

 To define the responsibilities of Quality Unit.

2. Scope:

This procedure is applicable to all personnel working in Quality Unit.

3.Responsibilities :

Quality Control, Quality Assurance, Microbiology Department

4. Procedure :

  • Quality should be the responsibility of all persons involved in manufacturing.
  • Each manufacturer should establish, document, and implement an effective system for managing quality that involves the active participation of management and appropriate manufacturing personnel. 
  • The system for managing quality should encompass the organisational structure, procedures, processes and resources, as well as activities necessary to ensure confidence that the API will meet its intended specifications for quality and purity.
  • All quality related activities should be defined and documented. 
  • There should be a quality unit(s) that is independent of production and that fulfills both quality assurance (QA) and quality control (QC) responsibilities. 
  • The persons authorized to release intermediates and APIs should be specified.
  • All quality related activities should be recorded at the time they are performed.
  • Any deviation from established procedures should be documented and explained. Critical deviations should be investigated, and the investigation and its conclusions should be documented.
  • No materials should be released or used before the satisfactory completion of evaluation by the quality unit(s) unless there are appropriate systems in place to allow for such use.
  • Procedures should exist for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g., quality related complaints, recalls, regulatory actions, etc.).
  • The quality unit(s) should review and approve all appropriate quality-related documents.
  • The main responsibilities of the independent quality unit(s) should not be delegated.
  • These responsibilities should be described in writing and should include but not necessarily be limited to:

-Releasing or rejecting all APIs.  Releasing or rejecting intermediates for use outside the control of the manufacturing company;

-Establishing a system to release or reject raw materials, intermediates, packaging and labeling materials;

-Reviewing completed batch production and laboratory control records of critical process steps before release of the API for distribution;

-Making sure that critical deviations are investigated and resolved;

-Approving all specifications and master production instructions;

-Approving all procedures impacting the quality of intermediates or APIs;

-Making sure that internal audits (self-inspections) are performed;

-Approving intermediate and API contract manufacturers; 

-Approving changes that potentially impact intermediate or API quality;

-Reviewing and approving validation protocols and reports; 

-Making sure that quality related complaints are investigated and resolved;

– Making sure that effective systems are used for maintaining and calibrating critical equipment;

-Making sure that materials are appropriately tested and the results are reported;

-Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates where appropriate;

-Performing product quality reviews

5. Abbreviations :

  API : Active Pharmaceutical Ingredient

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