For Production and Process Controls, designed to ensure that the drug product has the authenticity, potency, quality, and purity that it advocates or possesses,
and process control procedure designed to ensure that the drug product has the authenticity, potency, quality, and purity claimed or possessed.

List of Forms
The following forms are included with your purchase.
MD-QMS-S701 Production and Process Controls Procedure

Table of Contents

Procedure

1 Objective.
2 scope (of a document)
3 Definition of Terms
4 Roles and Responsibilities
5 Manufacturing Management
5.1 Preparation of manufacturing control procedures
5.2 Sub-materials for manufacturing
5.3 Validation of processes related to manufacturing and service provision
5.4 Handover to the next process
5.5 Management of client property
5.6 Special Requirements for Validation of Sterile and Sterile Barrier System Processes
5.7 Special Process Control
5.8 Ensure manufacturing control and quality control
5.9 Initial flow product management
5.1 Deviation Management
5.11 Change of process
6 infrastructure
6.1 Building and work area management
6.2 Equipment Qualification
6.3 Facilities Management
6.4 Procedures for implementing maintenance activities for equipment
7 Control of working environment and sanitation in manufacturing plants
7.1 work environment management
7.2 Personnel hygiene
7.3 Contamination Control
7.4 Product cleanliness control
8 Required Documents
8.1 manufacturing instructions
8.2 Manufacturing history book (other than manufacturing instructions)
9 Record keeping
10 Corrective and preventive action requirements
11 reference
12 by-laws