OBJECTIVE:

• To define the procedure for preparation, review, approval, implementation, and periodic review of Technical Quality Agreements (TQAs) between the manufacturing site and external parties (contract manufacturer, contract laboratory, API supplier, or product importer) to ensure compliance with EU-GMP / WHO GMP / local regulatory requirements.

 SCOPE:

• This procedure applies to all contract manufacturing, testing, storage, distribution, importation, and related quality activities performed by or on behalf of Company. It covers both outgoing and incoming technical quality agreements.

RESPONSIBILITIES:

Quality Assurance (QA):

• • • Initiation, drafting,
    • Coordination, review of all quality-related clauses,
    • Maintenance of TQA master list,
    • Ensuring compliance with Regulatory requirements.

Regulatory Affairs (RA):

• • Ensuring alignment with regulatory submissions and marketing authorization requirements.

Pharmacovigilance (PV):

• • Ensuring alignment with Pharmacovigilance Requirements

Quality Control (QC):

• • Review of analytical responsibilities,
  • Method transfer Responsibilities,
  • Testing, and sample retention sections.

Legal / Management:

• • Final legal review and signature authorization.

 DEFINATIONS:

• TQA: A legally binding agreement between two GMP-compliant entities defining their respective responsibilities regarding product quality.
•  Contract Giver: The company outsourcing activities.
•  Contract Acceptor: The company performing the outsourced activity.

PROCEDURE:

Initiation:

• QA shall identify the need for a TQA whenever there is a new contract activity, vendor approval, or change in existing arrangement.
• QA shall prepare a TQA Initiation Form specifying the activity, parties involved, and scope.

Draft Preparation:

• • QA prepares a draft using the TQA Template (Annexure-II) ensuring clauses cover:
    • Product details and scope
    • GMP responsibilities
    • Documentation, deviation, change control
    • Batch release, recall, market complaints
    • Validation and qualification
    • Stability studies, sample retention
    • Audit and inspection rights
    • Data integrity, 21 CFR Part 11 compliance
    • Pharmacovigilance (for marketed products)
    • Waste disposal
    • Confidentiality and duration of agreement

Review:

• The draft is circulated to internal departments and the contracting partner for comments.
•  QA consolidates comments and finalizes the agreement.

Approval & Execution:

• Both parties sign and date the final version.

• Original signed copies are maintained by QA, with controlled copies to concerned departments.

Distribution & Control:

• QA maintains a TQA Master Register with:
• • • Agreement No.
    • Parties involved
    • Effective & expiry dates
    • Review due date
    • Status (Active / Obsolete)

 Review & Revision:

• TQAs shall be reviewed once every five years or upon:
• • • Change in process, equipment, facility, or ownership
    • Regulatory inspection findings
    • Change in product responsibility or legislation
    • Any party wants to dissolve with prior notice of three months.

 Retention:

• All signed and obsolete TQAs shall be archived for minimum 05 years.

 TQA Numbering:

• The pattern for numbering shall follow as TQA/QA/XXX/YYYY, it includes:
  • • TQA: Technical Quality Agreement
    • QA: Quality Assurance
    • XXX: Serial number
    • YYYY: Year

REFERENCE:

• EU GMP Part I, Chapter 7: Outsourced Activities
• WHO Technical Report Series 986, Annex 2
• EudraLex Volume 4, Chapter 1 & 7

RECORDS:

 REVISION HISTORY: