This SOP defines the procedure for preparing technical agreement with contract givers.
2.0 SCOPE:
This SOP applies to the technical agreements made with contract givers for the manufacturing of pharmaceutical formulation by Alkem Laboratories Limited.
3.0 RESPONSIBILITY:
3.1 Head – Regulatory & corporate QA or his designee
3.1.1 Evaluating the technical agreement with the checklist.
3.1.2 Liaising with the contract giver for resolution of any technical issue.
4.0 ACCOUNTABILITY:
Head- Corporate Quality Assurance (CQA) or his designee
5.0 PROCEDURE:
5.1 Purpose of Technical Agreement
5.1.1 A technical agreement clarifies the functional and technical aspects of a business relationship. It will delineate, in significant detail, the responsibilities of quality, regulatory, production, storage and distribution within each company.
5.1.2 The Technical Agreement will enhance the communication and build the confidence between the two parties and avoid conflicts and jargon.
5.2 Contents of Technical Agreement
5.2.1 Technical agreement defines the responsibilities of contract giver and contract acceptor.
5.2.2 A typical technical agreement is composed of the major following sections:
5.2.2.1 Purpose and Scope
5.2.2.2 Definitions
5.2.2.3 Responsibilities
5.2.2.4 Contact List
5.2.2.5 List of products covered under this agreement
5.2.2.6 Approval
5.2.2.7 Changes and Revisions.
5.2.3 Detailed technical details of the subject products can be included as pert of the main technical agreement or as an attachment to the technical agreement.
5.3 Approval of Technical Agreement
5.3.1 Technical agreement is mutually agreed document and shall be signed both by Alkem and the contract giver.
5.3.2 Any revisions or addendums shall be approved by both the parties.
6.0 TRAINING:
Trainer : Head – Corporate Quality Assurance
Trainees : Regulatory & Corporate QA department
7.0 DISTRIBUTION:
Certified Copy No. 1 : Head – Regulatory
Master Copy : Head – Corporate Quality Assurance & Regulatory
8.0 ANNEXURES:
Annexure 1: Checklist for Technical Agreement
9.0 REFERENCE:
In house.
10.0 REVISION HISTORY:
ANNEXURE – 1
CHECKLIST FOR TECHNICAL AGREEMENT
REF. SOP NO.: CQA/011-00 Page No.: 1 of 4
AGREEMENT DETAILS:
Contract Giver:
Name of Product:
Strength:
M.A/PL no.:
Alkem’s Manufacturing Location:
DETAILS OF THE LIST:
A. Product Details:
B. Packaging Material:
C. Manufacturing & Packaging details:
D. BATCH RECORD AND PRODUCTION DOCUMENTATION:
E. SAMPLING AND TESTING
F. Product Release:
G. STORAGE, TRANSPORT AND PACKAGING DETAILS
FOR DISPATCH:
H. RESPONSIBILITY:
Note: Indicate the responsibility with ‘ X’ as applicable.Other than the above-mentioned responsibilities the contract giver and contract acceptor shall be responsible for the following:
I. COMPLAINTS:
J. RECALL:
K. INSPECTION:
L. CHANGE CONTROL:
M. .PERSON TO WHOM COMMUNICATION SHOULD BE ADDRESSED:
1. Name and responsibility and address with contact details shall be mentioned as in below:
Details of the responsible persons with address to whom communication should be addressed:
N. PRODUCT QUALITY REVIEW:
O. MARKETING AUTHORIZATION AND VARIATION FILING:
Q. CONFIDENTIALLITY:
