6. 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 theWorld Health Organization (WHO).
2) All printed pkg materials (A Group Company of Vivimedlabs ltd.) to be
incorporated in all klar sehen products.
3) New hepa filters to be installed and replaced by old hepa filters.
4) Manufacturing filter process changed .
5) API Specification change.
8. 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.
9. 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:
10. 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: -
11. 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.
12. 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
13. 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)
14.
15. 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).
16. 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
17. 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.
18. 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).
