What is Change Control ? : Pharmaceutical Guidelines

Editable Pharmaceutical Documents in MS-Word Format

View

8

What is Change Control ?

Changes should be reported through change control system in Production, Quality control, Quality assurance, Stores, Engineering and R&D departments.
In pharmaceutical industries change control has an important role. In pharmaceuticals, every change is reported by change control process.

When a change is being made in any process or procedure it is reported by change control procedure and that is approved by the company authority. Change control is used to control the changes made in the pharmaceutical industry.

Following are the changes which are to be reported by change management process:
a. Production
• Change in Location.
• Change in Equipment.
• Critical Process control parameters.
• Change in Batch size.

b. Engineering
• Change in any equipment.
• Critical Part of any equipment.
• Facility, Design layout.

c. Research & Development
• Change in Specifications of Raw Material/Packaging Material/Finished product.
• Addition / Deletion of any Raw material in the product.
• Change in quantity of Raw material in the product.
• Addition / Deletion of any manufacturing Steps.
• Change in Shelf Life.
• Change in Environmental Conditions.
• Change in Specifications of In-process / Intermediate materials.
• Change in Storage conditions.
• Change in method of analysis or change in sampling plans and method.
• Change in Hardware / Software of any Computerized Analytical Instruments.
• Change in Stability Protocols.

d. Materials (Raw & Packaging Material)
• Change in source of any Raw Material or primary packaging material.

e. Quality Control
• Change in method of analysis or change in sampling plans and method.
• Change in Hardware / Software of any Computerized Analytical Instruments.
• Change in Stability Protocols.
• Change in specifications of Raw Material / Packaging Material / Finished product.
• Change in Specifications of In Process / Intermediate Materials.

f. Quality Assurance
• Change in Sampling Plan/Quantity of Samples.
• Change in Documents and SOPs.
• Change in Validation Protocols.

g. Information Technology
• Change in Hardware / Software.

h. Cleaning Procedure
• Change in cleaning steps.
• Change in cleaning aids.
• Change in cleaning agents 







Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


Click Here

2 comments: Post Yours! Read Comment Policy ▼


Popular Categories

QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters

Follow Pharmaguideline


DOCUMENTS

PHARMACEUTICAL DOCUMENTS




Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...

View


adsbypg

Discussion - Latest Topics

Show All ❭❭Pharmaguideline Forum



GET APP FOR NEWS UPDATES

Scan to Download

Android App
Android App

Recent Posts