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Thursday, March 9, 2017

What is Change Control, Complaints, Contract Manufacturer ? How to handle Changes? What ICH Q7 tells about Change control ?



The chapter is in continuation of Easy Learning ICH series. The shortest chapters of the document are discussed.  There are 3 sections in the document which does not have any sub section
·         Change Controls (Section 13)
·         Complaints and Recall (Section 15)  
·         Contract Manufacturer (including Contract Laboratories) (Section 16)       
(Learning Trick:- The section initiate with the letter “C” has no subsection in ICH)

 Change Control (Section 13)

Change control is a systematic approach to manage all the changes made to a product or systems. The purpose is that all changes identified, reviewed, approved, archived and very well evaluated.

The changes can be segregated as:

Type A changeswhich include changes in
·         Raw material,
·         Packaging material
·         Specifications
·         Analytical method
·         Equipment (including computer hardware)
·         Support system
·         Processing steps
·         Labeling
·         Packaging Material

Type B Changes- which include GMP relevant changes

How to handle Type A changes

Written procedure must be established for handling change control. 


If any change that can affect the retest or expiry date must be evaluated in detail and If necessary the sample produced by the modified change must be placed for accelerated stability program and/or can be added to a stability monitoring program.


How to handle Type B changes
Type B changes are drafted, reviewed and approved by the appropriate organizational units and reviewed and approved by the quality unit.



Complaints and Recall (Section 15)
The ICH Q7 talks only about quality related complaint. Therefore it is essential to categorize the complaint. The quality related complaint whether received orally or in writing should be recorded and a well-defined procedure to handle such quality related complaint should be made available.

The complaint record should have at least below information:

·  Name and address of the complainant. [Here Name and address of the complainant refers to the Name and Address of the company]

·    Name (and where appropriate, title) and phone number of the person submitting the complaint.

· Product name and Batch No.

· Complaint nature

·Date on which complaint is received.

· Initial action taken or correction taken (including dates and identity of person taking                     the action)

·Any corrective action

· Response provided


A well-defined procedure should be established for customer complaints and product recall.

Essentials of product recall procedures

·                  The parties involved to evaluate the situation
·                  How a recall should be initiated
·                  Who should be informed about the recall.[In case of life threatening situation local,                           national and/or international authorities should be informed and there advice should                     be taken.
·                  How the recalled material should be treated.

Contract Manufacturer (including Laboratories) (Section 16)

Contract Manufacturers are those who manufacture a product on behalf of the contract giver. In other words the contract giver is outsourcing the product which is manufactured at contract manufacturers site. This is to be noted that the contract giver is fully liable for any issues which is raised due to any violation at contract manufacturer. There should be a written procedure that is signed at both ends which defines the GMP and its responsibility in detail.

In ICH the testing which are outsourced are included in the category of Contract Manufacturer. All contract manufacturers should follow all the required GMP defined in the ICH-Q7 with an additional emphasis on prevention of cross contamination and foolproof traceability. Contract manufacturer must have an independent quality unit that follows the entire requirement specified in section 2.22 in ICH. The contract giver is fully liable for any loopholes that exist at the premises of the contract manufacturer. He has to, therefore, do an assessment at a defined interval at the contract manufacturer and should track the closure.

In case a sub-contracting is permitted than it should not be given to any third party without the permission of the contract giver.


Qualification: Masters in Industrial Biotechnology Management from Lille Catholic UniveersitySpecialization in QHSE in food and Pharmaceutical Industry.

Next Article Title:  Quality Unit and its Functions
[Easy Learning ICH Q7 Part 3]



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