Importance of Change control in Pharmaceutical Industry: A Review

Yogita Chowdhary, Babita kumar

Sanskar College of Pharmacy and Research, Ghaziabad - 201001

*Corresponding Author E-mail: Yogitachowdhary85@gmail.com

ABSTRACT:

Change Control is the process that management uses to identify, document and authorize changes to an IT environment. It minimizes the likelihood of disruptions, unauthorized alterations and errors. The change control procedures should be designed with the size and complexity of the environment in mind. Change control is used to ensure changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without forethought, introducing faults into the system or undoing changes made by other users of software. The goals of a change control procedure usually include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing change. Change control is used in various industries, including in IT, software development, the pharmaceutical industry, the medical device industry, and other engineering/manufacturing industries. For the IT and software industries, change control is a major aspect of the broader discipline of change management. There are two types of changes 1. Disruptive change 2. Dynamic change. is a non-localized future irreversible and change that affects a portion of an industry. This can be caused by changes in market trends causing a shift in the mode of production to fit the customer demands. Dynamic Change is multi-dimensional change that is predictable on a measurable scale. Change control is a CGMP concept that focuses on managing change to prevent unintended consequences. Manufacturing changes (i.e changes that alter specifications, a critical product attribute or bioavailability) require regulatory filings and prior regulatory approval.

KEYWORDS: Change Control, Pharmaceutical Industry.

INTRODUCTION:

In pharmaceutical industry change control is an important part of quality assurance. The changes proposed and made in any procedure or process should be reviewed, established, documented and approved by the concerned authorities¹. Change control is the system to implement this approved change to confirm². The regulatory requirements.

The Change Control Form (CCF) is an important documentation part of change control. It contains the form related to initiate department for the proposed change, proposed change details, comments from QA Head, category of the changes, supportive documents, management review form and assessment of CCF³. The primary objectives of change management are to: manage each change request from initiation through to closure; process change requests based upon direction from the appropriate authority; communicate the impact of changes to appropriate personnel and allow small changes to be managed⁴. The goals of change control process is Support timely and effective implementation of business-required⁵ changes is appropriately manage risk to the business. Minimize negative impact of changes to/for the business. ensure changes achieve desired business outcomes.

Table 1 :Six steps to control change control

1.Scope⁶	Include aspects such as identifying the change, its owner(s), how it will be communicated and executed, how success will be verified, the change's estimate of importance, its added value,
2.Analyse	Identify low-risk. High-risk change.
3. Review	A review and approval process is required by Manager.
4. Implement	Implementation by team to approved plan but also according to organizational standards, industry standards, and quality management standards.
5.Close	After completion of project providing tangible proof of project success.

CONCLUSION:

Change control is the process through which all requests to change the approved baseline of a project, programme or portfolio are captured, evaluated and then approved, rejected or deferred. Implementation of a new technology. Mergers and acquisitions. Change in leadership. Change in organizational culture. Change control is a CGMP concept that focuses on managing change to prevent unintended consequences. Certain manufacturing changes (i.e changes that alter specifications, a critical product attribute or bioavailability) require regulatory filings and prior regulatory approval.

REFRENCE:

1. Matteson, S. (7 July 2017). "10 essential elements of change control management". TechRepublic. CBS Interactive, Inc. Retrieved 20 May 2018.

2. Hall, P.A.V.; Ramil, J.C.F. (2007). Managing the Software Enterprise: Software Engineering and Information Systems in Context. Cengage Learning. pp. 318–325. Retrieved 20 May 2018.

3. Turner, S.G. (15 December 2003). Pharmaceutical Engineering Change Control. Taylor and Francis. pp. 200.

4. Teixeira, M.B. (2013). Design Controls for the Medical Device Industry (2nd ed.). CRC Press. p. 205.

5. Monahanm E. (1995). Engineering Documentation Control Practices & Procedures. CRC Press. p. 280.

6. Herzig, T.W.; Walsh, T.; Gallagher, L.A. (2013). Implementing Information Security in Healthcare: Building a Security Program. Healthcare Information and Management Systems Society. pp. 204–205.

Received on 11.04.2022 Modified on 18.09.2022

Asian J. Pharm. Ana. 2023; 13(1):59-60.

DOI: 10.52711/2231-5675.2023.00010

4. Implement