Q06-5000 Control of Outsourced Operations

What is CONTROL OF OUTSOURCED OPERATIONS?

In the pharmaceutical industry, outsourcing is common for various activities, such as manufacturing, packaging, testing, and distribution. Pharmaceutical companies often collaborate with external suppliers and service providers to streamline their operations.

Below are some of the Regulatory GMP Requirements and Guidelines:

(1) ISO9001: 2015 (E), Quality management systems — Requirements.
Clause 8.4 Control of externally provided processes, products and services.
–   “The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. The organization shall retain documented information of these activities and any necessary actions arising from the evaluations.”

(2)  Pharmaceutical Inspection Co-operation Scheme (PIC/s) PE 009 – Guide to GMP for Medicinal Products.
Chapter 7 – Outsourced Activities:
–  “…Any activity covered by the GMP Guide that is outsourced should be appropriately defined, agreed and controlled in order to avoid misunderstandings which could result in a product or operation of unsatisfactory quality….”
–  “This Chapter deals with the responsibilities of manufacturers towards the Competent Regulatory Authorities with respect to the granting of marketing and manufacturing authorisations.”

(3) FDA Q9(R1) Quality Risk Management – Guidance for Industry.
Annex II, Section E. Quality Risk Management as Part of Materials Management Assessment and Evaluation of Suppliers and Contract Manufacturers (II.5):
–  To provide a comprehensive evaluation of suppliers and contract manufacturers (e.g., auditing, supplier quality agreements).

Accordingly, we have the following SOPs and forms for you to implement “Control of Outsourced Operations”:

(1) Q06-5001 Supplier Management

(2) Q06-5002 Supplier Contract Management
Form: Q06-5002F01 Supplier GMP Agreement
Form: Q06-5002F02 Supplier Laboratory Services Agreement
Form: Q06-5002F03 Supplier Material Supply Agreement

(3) Q06-5003 Supplier Audit
Form: Q06-5003F02 Audit Summary Report
Form: Q06-5003F03 Supplier Audit Request Form
Form: Q06-5003F04 GMP Questionnaire for Distributor (Repackaging)
Form: Q06-5003F05 GMP Questionnaire for Distributor (No Repackaging)
Form: Q06-5003F06 GMP Questionnaire for Excipient Manufacturers
Form: Q06-5003F07 GMP Questionnaire for Packaging Suppliers
Form: Q06-5003F08 Supplier Audit Schedule Template
Form: Q06-5003F09 Supplier Pre-Audit Questionnaire