Change control

change control application in pharma industry

1. CHANGE IN MIND

2. CHANGE IN E MOTION

3. Case study 1)nearly 100 deaths resulted from cough syrup (distributed to children in Haiti between 1995 and 1996) that was contaminated with diethylene glycol, according to the World Health Organization (WHO ). 2) All printed pkg materials (A Group Company of Vivimedlabs ltd.) to be incorporated in all klar sehen products. New hepa filters to be installed and replaced by old hepa filters. Manufacturing filter process changed . API Specification change.

4. CHANGE CONTROL IN PHARMA INDUSTRY

5. Change control is a systematic approach to managing all changes made to a product or system. The purpose is to ensure that no unnecessary changes are made, that all changes are documented, that services are not unnecessarily disrupted and that resources are used efficiently.

6. Procedure for change control in pharmaceuticals 1.0          Purpose: To describe a procedure for change control. 2.0          Scope: This SOP shall be applicable for the identification, documentation, appropriate review and approval of changes in raw materials, specifications, analytical methods, facilities, support systems, equipment (including computer hardware) processing steps, labeling and packaging materials, and computer software. 3.0         Responsibility: Designee of Originating Department:          

7. 4.0         Procedure: 1.          The initiating department shall initiate the change as per the change control format no. 2.          The initiating department shall furnish the details very clearly in the form for present process/use, proposed change, Justification & impact analysis and acceptance criteria. 3.          The initiating department shall also define changes as major or minor based on product quality or its impact of safety, health and environmental aspects. Some of the major and minor changes are listed below: -

8. 3.1        Major Changes For a substance of chemical and microbiological quality evaluation . •         Addition or deletion of a step or addition of an alternative/new step in the formulation manufacturing process. •         Addition of a new manufacturing site with modification of the formulation manufacturing process described in the original dossier/document. •         Change in input quantities of formulation manufacturing process. •         Changes in the quality of raw material(s) or key intermediate(s) used in the formulation manufacturing process. etc.

9. 3.2.    Minor Changes •           Change in the administrative references (name/company name, address) of the certificate holder. •         Change in the references (name/company name, address) of the manufacturing site. •         Change or updating of the methods of analysis used to test the substance. •         Change in the specifications of the substance. •         Change in supplier of starting and packing material. •         Change in the batch size. •         Addition of a new manufacturing site in the same site as described in the original dossier. •         Change in the documents like SOPs etc

10. Assigning a change control number       Each change control number contains seven digits. -     First two digits represents change control code. -  Third, forth and fifth digit represent sequential change control No. (001 to 999) -     Sixth and seventh digit represents last two digits of the current year. (e.g.01, 02, 03…...99). For example, following change control no is decoded as explained. CC-001/ 03. CC = Change control code. 001= Sequential Change control Number (001, 002, 003…………..999).  13= Current year 2013 (Last two digit of current year )

11. The following are examples of changes that wouldn’t normally require prior approval: – Editorial changes to procedures (typographical, grammatical/presentation updates or which provide additional detail/clarity in describing an existing established practice) – Environmental control changes which do not affect the processes or product – Operator safety changes which do not affect the process or the product. – Like-for-like changes of equipment or parts. – Routine and preventive maintenance updates that do not have an associated change to an operating parameter. – Changes to procedures that do not describe activities directly involved in the manufacture, packaging, analysis or release of product (i.e., training or document control procedure changes).

12. Key Benefits of Change Control System The following are the key benefits in using a change control system: Structured and consistent approach towards managing change Documenting the details of change Routing of change requests to appropriate individuals/team for approvals Documentation of change approvals and implementation Maintenance of change history and easy retrieval of information Tracking changes effectively and providing an audit trail Demonstrate compliance to FDA regulations

13. As part of the cGMPs under 21 CFR Parts 210-211 , PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS PART 210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL pharmaceutical companies are required to control any change to established processes – meaning the change has to be recorded, reviewed and approved by the QA/QC unit.

14. Certain major manufacturing changes (e.g., changes that alter specifications, a critical product attribute or bioavailability) require regulatory filings and prior regulatory approval (21 CFR 314.70, 514.8, and 601.12).

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