The term "change" is something that we all experience both in life and in our business. While some of us might embrace it and seek the challenges, there are often more that do not like it and are resistant to the implications that change may have. The big difference between the two attitudes is that in life, we face the change, accept it and move on. We do not formalize the event by a series of documents, reviews, evaluations and approvals. In regulated industries, such as pharmaceuticals, biotechnology, and medical devices, the opposite is required and therein are the challenges.
Maintaining the validated state of equipment, utilities and processes is a basic component of a quality system as defined in current regulations and to that end, changes made to these items need to be documented through a formal change control program. The composition of a change control program can be as different as companies themselves, but the basic expectations of such programs can be summarized into the following areas:
Assuming these factors are covered in the procedures and forms used, the timely close-out of changes remains an issue not only with companies but also with regulators during audits of these programs.
Current regulations and guidance documents do not specify a format to use or a time period in which the change and its documentation must be completed. Deficiencies cited for time periods needed to close out a change control are usually the result of what the company stated in its procedure but were unable to meet. I often advise establishing a "delay period" for use when a proposed change is approved for implementation but held up for several months for a variety of reasons. If the time period for implementation is exceeded, usually by several months, the original change is voided and the reasons are given. If the need remains, then the change control process is repeated.
Changes in corporate QA policies and practices, along with changes in the regulatory environment, are behind the rationale. What might have been acceptable months earlier may no longer be applicable today. One of the most common factors that influence the closeout of change controls, other than the complexity of the change itself, is the number of reviewers assigned to review them. The more reviewers, the longer the review process and potential open issues. More importantly, the reviewers need to be knowledgeable of the impact the change has and subsequently, the testing required in proving its acceptability.
A second common deficiency with change control programs is the failure to follow up on the item changed to verify that the intended purpose, whether to correct a problem, improve a process or to reduce manufacturing errors, met its goals. This is done by trending of data and periodic reviews of subsequent lots.
Whatever your procedure is for change control, keep three things in mind: make it concise so people will read it and understand their responsibilities, make it logical so you can maintain and adhere to it and finally, make it defendable when challenged by a regulatory auditor!
Kenneth Christie has more than 20 years of sterile manufacturing experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, Massachusetts. He is responsible for both business development planning and Validation and Regulatory Consulting services on a global basis. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic and solid dosage processing equipment, utilities, and systems.
Prior to joining VTS, Mr. Christie was the Validation Manager at Parke-Davis' Sterile Products Facility in Rochester, MI. While there, he was involved in the review and approval of all facility, equipment, and system commissioning/qualification activities. Additional responsibilities included routine interaction with the FDA and European inspectors, corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.
Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie serves as a member of the ISPE Professional Certification (PCC) Commission Examination Development Committee (EDC), which is industry's first attempt to "certify" industry professionals based on proven regulatory knowledge. Contact him at (413) 253-0077 or at firstname.lastname@example.org.
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