Sigma Ltd

Sigma LtdYou will be able to knowWhat a change control system is?Why a change control system is needed?

Sigma Ltd DefinitionA change is any variation that may impact consistent product quality. e.g., modification to documentation, equipment, packaging, utilities, facilities, formulations, process or computer system Change is of two Types:TemporaryPermanent

Sigma Ltd Impact of ChangeThe change may or may not impact the safety, quality, purity or potency of a product throughout its shelf life.There must be a written change control procedure (SOP).Change Control procedure also ensure documentation supporting the change is maintained and easily retrievable.

Sigma Ltd Who can initiate the changeAny one can initiate the change by filling change control form giving the detail reason of change, date of initiation and name & signature of the person.The change control form will be reviewed by department head and other appropriate personnel for the proposed changes and provisions for filing the change with the appropriate Regulatory Authorities.

Sigma Ltd ContdAnd approved by Quality Assurance. Person who initiate the change is responsible for the change. There should be a team of Quality Assurance, Production, Engineering, Regulatory, or if required Marketing, Purchase, R&D and Packaging Development can be involved for deciding about the change.

Sigma Ltd Classification of Change:There are three level of changes:High : Very likely to impact the product.Medium : were somewhat likely to impact the productLow or Emergency changes: were anticipated to have no or a negligible impact on the product.

Sigma Ltd ContdThe level of change indicated the probability or likelihood that the proposed change could impact the product.

Sigma Ltd Time Frame for Implementation of Change Changes requiring different levels of priority and urgency.Turn around time for changes request to review to implementationGeneration of sufficient supporting data in a timely manner.

Sigma Ltd Documentation of Change:All changes must have supporting documents. A finished product cannot be released until the document is completed and the change has been signed off by the appropriate quality representative.

Sigma LtdDocumentation of ChangeEmergency changes may be made only if the documentation is completed and filed, including the QA approval within a limited time.Document should support the change made.

Sigma LtdFailure of Change Control System:Change control implementation fails because:Lack of communication between the depts.Lack of follow-up on emergency changes, deviation requests, or unplanned changes

Sigma Ltd ContdChanges made by suppliers without proper and timely notification.Changes implemented without proper notification to the persons who are affected by the change.Although GMP require this type of document prior to batch release, this is sometimes overlooked in the urgency to meet an order.

Sigma LtdContdOnce the batch is released, the completion of necessary change requirement is often given a lower priority and frequently not completed.Our companys first priority is patient safety and quality, not shipping the product out the door.

Sigma LtdContdUnreported changes made by suppliers are often the most difficult to handle as the supplier is not automatically subject to our companys policies and procedures and culture.

Sigma Ltd Solution to Overcome failure:A Change control committee should be formed which bring together the initiator of the change and responsible individuals from all departments affected by the change.There must be procedure to control, release of lots manufactured with changes that are not yet approved according to the appropriate change control procedure.

Sigma Ltd ContdAll change requirements are completed prior the change being filed as complete and prior to the release of any affected batches.Suppliers contact copy should have understanding on Quality Agreement showing that the supplier agrees to follow our companys change control policies and report to us in a timely manner.

Sigma LtdContdChanges being made with proper training given to the operator regarding the change.In case, other documents are affected by the proposed change is also helpful in assuring that all SOPs are kept up-to-date as changes are made.

Sigma Ltd DataData attached with the change control should be sufficient to support the change.

Sigma Ltd ConclusionThere are 5 essential, but critical points of any pharmaceutical change control process. These are:TrainingCommunicationEarly & Continual Regulatory InvolvementDocumentationCo-operationAll aforesaid points must be present for any change control process to function smoothly.

Sigma Ltd Prepared ByS. MURKIKAR Manager Quality Assurance SIGMA LABS LTD

Sigma Ltd

Quality Assurance Department, Cephalosporin Division, Wockhardt Limited, Waluj, Aurangabad - 431 136