Change Control in Pharmaceutical Quality Management System
Aravindan N, Seetharaman, Raju Kamaraj
Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy,
SRM Institute of Science and Technology, Kattankulathur – 603203, Kanchipuram, Tamil Nadu, India.
*Corresponding Author E-mail: aravindan1306@gmail.com
ABSTRACT:
Change management system is a Some Licensed members of relevant disciplines inspect the proposed changes that alter the status of facilities, equipment or process and The Change control management is focus on change to prevent unplanned impact in pharma industry. Ensures that the changes should not affect the product quality or safety. The goal of the CC is a inhibit of control request. There are three stages of change control process. The first step of the company is to follow Good Manufacturing Practices (GMP). Firms must store the details of manufacturing, quality control, materials required and several other things required in this procedure. The change control committee is mainly working in different process its consists of head of quality assurance, manufacturing, sales and various other members. The major objective is to evaluate changes, determine the measure and provide final authorization and CCM is linked to multiple parts of an enterprise quality management system [EQMS].
KEYWORDS: Change control management, post approval change, marketing authorization.
INTRODUCTION:
SCOPE:
This protocol document applies for all medicinal produce for both mankind and veterinary utilization. This applies to all different products irrespective of way they developed the product2.
POST APPROVAL CHANGE MANAGEMENT PROTOCOL:
Post approval change management protocol tells us how unique modifications that company like to achieve in due course of product development. It is careful evaluation of each and every step in product development and collect the data and evaluation of it to produce desired results 1 This step wise approach helps in faster implementation of changes in post approval. Regulatory authorities will scrutinize the product quaity3,4.
Change management system Some Licensed members of relevant disciplines inspect the proposed changes that alter the status of facilities, equipment or process. This process is to make sure that the system is kept in validated state5.
HISTORY OF CHANGE MANAGEMENT:
Change management that started in 1980 initiated by top 50 companies of the era like Ford, GE and AT&T. Right now this course is via through consulting services, limited to number of books and textbooks only6.
During 1990 when industrialization is at its peak in IT and human resource, its highlighted importance of change management programs. Change management although widely used but primarily incomplete to large corporations7.8.
The 2000's change management is perceived to be game changer. This played major role by increasing from 34% in 2003 to 72% in 2011.This is checked by some MLC'S like IBM McKinsey
The market for change management tools has grew to an extend that 320 firms recognized as offering change management facilities by 2011 Some use their own change management procedures while some use already offered consulting services9.10.
CHANGE MANAGEMENT SYSTEM:
Change management system is act on both prior regulatory submission and post submission.
CHANGE MANAGEMENT PROCESS:
Change control management is focus on change to prevent unplanned impact in pharma industry. Ensures that the changes should not affect the product quality or safety. The steps involved in change control management process are:
Request for change:
Change requests are collect and generally documented in the form of a change request, the change is declined by change control committee (CCC)11,12.
Post approval change management is requested by the company would like to implement during the lifecycle.
Impact analysis:
· Low to medium change impact (20-40).
· Medium to high change impact (40-60).
· High change impact (60-100).
Approve/cancel:
Change control board (CCB) decided to make the change they will approved the change request after evaluation. If Change control board (CCB) decided not to make the change they will reject. Change was canceled backout of modifications they will canceled the change request13.
Implement change
Review/reporting:
The report contains formulation, justification for all changes made in the process, during the development of the process for example:
· Justification for all material used,
· Justification type of equipment used,
· Justification for all analytical procedure used,
To increase the production level,
Final test finding, in process finding.
All changes should be documented, requested, accepted by quality control, quality assurance R & D, Engineering and Regulatory affairs14.
List of the changes are:
Following changes are reported by change management process:
· Production - change the batch size, location, equipment.
· Engineering – critical stage of any equipment’s, design layout, change in apparatus, equipment.
· Materials – change in raw material or primary material, packing material.
· Quality control – change in method, Raw material, packing material, finished product, intermediate materials and computerized analytical instruments.
· Quality assurance – change in documents, sampling, validation
· Research and development- change in shelf life, quality of materials and environment.
· Cleaning procedure – change the cleaning methods, aids, agents.
· Information technology- change the hardware and software15,16.
AREAS REQUIRING CHANGE MANAGEMENT:
CCM is linked to multiple parts of an enterprise quality management system [EQMS]. We have to mainly focus on these areas to control the changes. Equipment, machines and instruments
· Documents
· Materials (raw materials, packing materials)
· Automation system
· Batch
· Hardware/network applications
· Regulatory changes
· Packaging/labels.
GRADING OF CHANGES:
· Major change:
Major change may require authorization by the relevant regulatory or requalification. Changes to the process parameters and composition, possible measures are official license, new approval.
· Minor change:
Focus and/or change the cleaning process and cleaning agent for floors, as well as laundry for work clothing. To replacement the apparatus part of the same model. Possible measures are review, documentations and ext,
· Not requiring control:
Change to working times, fitting the Air conditioner in staff room.
GRADING OF CHANGES
Benefits of change management process:
· Defect in the process can be decreased.
· Timeline to implement the transition will be decrease.
· Enhance income of the company.
· Change management process is used to increase the customer service and effective service to clients and customers.
· Employees will aware of the each changes it could be enhance the performance of the employees.
· Formal and proper change management process will decrease the risk associated with the process and change.
· Investment on capital will be reduced and it will also helps to contain cost associated with change, Change is a planned and managed process.
· Identify and quantify, value and appraise, Plan, Realize, Review these are the steps are involved in benefits management.
CHANGE CONTROL PROCES:
The goal of the CC is a inhibit of control request. There are three stages of change control process. The first step of the company is to follow Good Manufacturing Practices (GMP). Firms must store the details of manufacturing, quality control, materials required and several other things required in this procedure. The company must follow the needs throughout the whole history of drug. The Firms must document all the necessary materials and also the change control for the requirements. Due to various technological development, manufacturers have to modify, redefine, enhance the requirements repeatedly. This change leads to review the approved requirements to keeps the system in its original form. This is the task of change control.
CHANGE CONTROL COMMITTEE:
This committee consists of head of quality assurance, manufacturing, sales and various other members. The major objective is to evaluate changes, determine the measure and provide final authorization. The main problem the committee face Is that it cannot deal with all the changes in a company. These changes could have an impact on GMP system, facility, product/procedure. A high involvement is transferred to other staffs in the company. If no one evaluates a critical change this may result in poor quality. The company can review the effectiveness of this system due to this committee. It includes,
1) Number of OOS results per year.
2) Number of internal and external complaints/year.
3) Work of expenditure/change.
4) Number of completed change procedures/year.
5) Stability problems/batch review/recalls, etc.,
It can measure the functionality by the effort and speed of change of procedures like deviations. The effectiveness depends upon the knowledge of the staff involved. The documentation procedure must be simple and easy to understand for rapid implementation. Deviations are unnecessary changes which is expressed in terms of indoor and outdoor complaints. The change control programs fails when the same problems appears repeatedly. It is possible that the change to a critical process parameter has been overlooked or there is negative trend in development of the process data.
Table – 1: Change Control deviation
|
Scope of Change |
Ownership of Change |
Consent to be taken from the departments other than QA/RA |
|
Documentation: New or Changes SOP / STP / Specification / Method of Analysis / BMR /ADR /BPR /GTP /Validation Protocol / Stability Protocols / Site Master File / Validation Master Plan / Formats / Art works / Supplier Qualification etc., |
Operating owner of the procedure |
Related user departments |
|
Facility: New or Changes Building of Manufacturing block / Warehouse / Utility / QC / Microbiology Lab / Other Parts of the premises / etc., |
Operating owner of the facility / Area |
Related user departments / Engineering services |
|
Process: New or change relate to site / Stream / batch size / Batch formula / Manufacturing process sequence / Process parameter / packing mode. Change related to cleaning and sanitation agent (shall be not applicable if addressed under DOCUMENTATION) / lubrication / lab chemical / Change relate to approved supplier / Change in art work / etc., |
Manufacturing Departments / QC Department (as applicable) |
Formulation Development / Analytical Development / Related user departments |
|
Equipment and Utilities: New or Changes relate to Manufacturing equipment / Change in accessories of equipment / QC instruments / Weighing equipment’s / Changes in capacity / Operating principle / etc., Critical utilities like HVAC, Water system, Compressed air, Air, Vacuum, Nitrogen, Dust extraction / etc., |
Manufacturing / Quality Control / Engineering Services (as applicable) |
Engineering services / Related user departments |
|
Software: New or changes relate to software of manufacturing equipment / Material inventory / Other critical utility / Testing equipment’s / Any other monitoring, Data processing and recording system / etc., |
Operating owner of the System / Equipment |
Engineering services / Related user departments |
CONCLUSION:
Change control management is mainly used to maintain the product quality or safety in the pharmaceutical industry and also ensure the product quality its should not affect because of changes. Change control management is linked and focus on multiple parts of the enterprise quality management system (EQMS) and change control management is does not act as a deletion of the changes its act as a control and ensure the product quality, safety, purity, effective and ext., Different types of changes is required based on process, treatment, product shelf life, effectiveness, cost, work time, equipment, employees and work space from different parts of professionals for example: Engineering, life sciences, medicine, pharmaceutical industry, marketing and ext., Change management system is guide the pharmaceutical industry to maintain the product quality its helpful for pharmaceutical quality system(PQS). Change management process is act on both prior regulatory submission and post submission. CCM is helpful to reduce the defect in the process, enhance income of the company, timeline to implement the transition will be decrease.
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Received on 29.07.2019 Modified on 28.09.2019
Accepted on 13.11.2019 © RJPT All right reserved
Research J. Pharm. and Tech. 2020; 13(4): 1985-1988.
DOI: 10.5958/0974-360X.2020.00357.1