RESPONSIBILITIES OF QUALITY UNIT

OBJECTIVE:

To provide a procedure which describes and documents the responsibilities of Quality Unit.

SCOPE:

This procedure is applicable to the Quality Units of the {Company Name} involved in the manufacturing, packaging, testing, release, storage and distribution of drug products.

RESPONSIBILITY:

Quality Assurance/Quality Control Officer/Executive/Designee: shall be responsible for following established procedures and ensuring compliance to cGMP requirements.

Head Quality shall be responsible for establishing the quality system structure throughout the respective manufacturing unit. Ensuring written (documented) job description are available for employees in responsible positions and are specific, clearly mentions the authority to carry out their responsibilities. To ensure no gaps or unexplained overlaps in responsibilities/job descriptions of personnel concerned with Good Manufacturing Practices. Ensuring delegation of responsibilities to designated deputies of satisfactory qualification level, and is documented.

ACCOUNTABILITY:

QA Head shall be Accountable for implementation of SOP.

PROCEDURE:

Quality unit is an organizational unit independent of production which fulfils both Quality Assurance and Quality Control responsibilities.

The Quality Unit shall have the responsibility and authority with respect to following activities;

• Initiate, implement and assure compliance to {Company Name} Policies and Procedures.
• Assure compliance with all applicable regulatory requirements including current Good Manufacturing Practices.

• Prepare, review and approve the quality documents viz. Site master file, validation master plan and Quality Manual.
• Interactions with regulatory agencies including handling of regulatory audits and assure fulfilment of regulatory commitment and submissions to regulatory agencies including recalls, market withdrawals and filing FDA field alerts or their equivalent in other markets.
• Approving changes that potentially impact product quality.

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• Ensure that process non conformances, material non conformances, out of specifications, out of trends, out of limits, near miss events, aberrant results and exceptions are investigated and timely resolved. The quality unit must participate in final approval of any such investigation and the subsequent corrective and preventive actions.
• Ensure complaints are investigated and appropriate measures to prevent reoccurrence are implemented.
• Ensure that controls are in place to document the receipt of returned goods, investigate the product accordingly and to compile a report summarizing the results of the investigations, as applicable.
• Ensure that raw materials including packaging materials and excipients from qualified suppliers are used in the drug product.
• Ensure Technical agreements are in place with providers of GMP regulated products & services and customers. Ensure compliance to technical agreements.
• Sample and inspect incoming raw materials, labeling, packaging materials, in-process and finished product.
• Perform laboratory testing of raw materials, containers, in-process materials, packaging materials and drug products using validated analytical methods against specifications.
• Ensure manufacturing process is carried out in accordance with cGMP, applicable regulations and written documentation.
• Perform and evaluation of in-process controls.
• Ensure that there is stability study program and stability data to support expiry dates and storage conditions of the products.
• Collection, storage, retention, retrieval and destruction of Reference Samples/Retention samples.
• Approve or reject active pharmaceutical ingredients, excipients, packaging materials, in-process materials and finished drug products.
• Prior to release of finished drug product, the quality unit shall review all applicable manufacturing and packaging records including analytical records to ensure that approved processes and procedures were followed.
• Approval of the destruction of any rejected or expired or quarantined raw materials, drug product container, closures, in-process materials, packaging materials, labelling or finished drug product.
• Release of all finished products manufactured and packed at a site.
• Ensure that the products are stored and distributed in compliance with Good Distribution Practices requirements.
• Review and approve standard operating procedures for all departments responsible for the receipt, processing, packaging, testing, storage and distribution of drug products.
• Prepare, review and approve specifications and Analytical methods impacting the identity, strength, quality, and purity of the drug products.
• Review and approve all labeling artwork.
• Review and approve master batch processing records and batch packaging records.
• Maintain all documentation for the processing, packaging, testing storage and distribution of drug product and its destruction after the retention period.
• Ensure timely training of all personnel as per training schedule and maintenance of training records.
• Maintain the validation program which provides a high degree of assurance that a specific process will constantly produce a product that meets its quality attributes.
• Reviewing and approving validation protocols and reports for facilities, equipment, manufacturing process, analytical method, cleaning validation and automated systems that may impact the strength, quality or purity of the finished product.
• Conduct and evaluate the cleaning validation program.
• Oversight of the site calibration and preventive maintenance programs.
• Conduct internal audits as per internal audit schedule and ensure compliance on non-conformances reported.
• Prepare, review and approve annual product quality reviews.
• Responsible to ensure quality risk management is applied to the decision making processes that affect product quality.
• To continuously enhance the overall quality and compliance level through effective management of quality management system.
• Implement the customer requirements in case of customer supplied products and review technical aspects of work contract.
• To conduct periodic quality review meeting with Head of Departments of various site functions, including senior management, where applicable.
• Ensure implementation of Safety, Health and Environmental policy requirements at the QC Lab.
• The activities of Quality Unit shall not substitute for, or preclude the daily responsibility of manufacturing personnel to build quality into the product.
• The Quality Unit should not take on the responsibilities of other functions of a manufacturer’s organization, such as but not limited to the responsibilities handled by production personnel, engineering, and development scientists etc.

Click the link to download word file copy of this document:
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REFERENCES:

21 CFR Part 211. 22: Responsibilities of Quality Control Unit

US FDA Guidance: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations

PE 009-9 (Part I): Guide to Good Manufacturing Practice for Medicinal Products

ANNEXURES: 

Not Applicable

ENCLOSURES: SOP Training Record.

DISTRIBUTION:

Master Copy                    :          Quality Assurance Department

Controlled Copy No. 01  :          Head Quality Assurance

Controlled Copy No. 02  :         Head Quality Control

ABBREVIATIONS:

REVISION HISTORY:             

CHANGE HISTORY LOG

Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/responsibilities-of-quality-unit/