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How To Know About Change Control Process in Pharmaceutical Industry || Pharma Guide

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Change Control Process In Pharmaceutical Industry

 

Definition:

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.

Change control process in different departments:

Production Department:

Change in Location:

When a product is manufacturing due to change in the surroundings result in changes.

Change in Equipment:

In this process, the equipment is adjusted to get correct results.

Change in Batch size:

By using change control format we can increase or decrease the change in batch size to get accurate results.

Change in the Critical process:

By the control of parameters in the critical process, we get desired results.

By the product specification, characteristic and proofs we can determine change control form.

Quality control department:

  • Change in sampling plan,
  • Change in sampling method,
  • Change in method of analysis,
  • Change in stability protocols,
  • Chang in analytical instruments,
  • Change in specification of Raw materials,
  • Change in specification of packing materials,
  • Change in the specification of Finished Products.

In this above processes by the tiny changes in the change control, we can get successive results.

In change control process Hardware and software, equipment is used to get accurate results.

 

 

Change in specifications of the In-process and Intermediate process:

By using change control process the tiny variation in Intermediate process and In-process we can get desired results.

Quality Assurance:

QA department of change control is depended on documents. These documents play an important role.

Change in sops:

By using change control format in Standard Operating Procedures we can get good results.

(SOP’s are changed according to each and every batch of products)

By the changes in the quantity of samples like increase or decrease we can get successive results as given below:

  • Change in quantity of samples,
  • Change in sampling plan etc.

Change in Validation Protocol:

By the tiny changes in the validation protocol, we can get exact results.

Research and Development:

In this R&D department there are small changes like addition or deletion in change control format we can get improved results as given below:

  • Change in sampling plan,
  • Change in sampling methods,
  • Change in method of analysis,
  • Change in analytical instruments,
  • Change in stability protocols,
  • Change in specifications of RM, PM, FP,
  • Change in quantity of RM,
  • Change in shelf life,
  • Change in environmental conditions,
  • Change in specifications of In-process or Intermediate process,
  • Change in storage conditions,
  • Change in hardware or software.

 

 

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