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here are the top 20 frequently asked questions about the change controls in pharmaceutical industry subscribe to channel for more informative content we will start with the very basic question what is Change Control answer is in simple words Change Control is the documented established procedure to control changes in pharmaceutical industry FDA defines it as change control is a systematic approach to managing all changes made to product or system whereas ichq10 defines it as a systematic approach to proposing evaluating approving implementing and reviewing the changes next important question what are the types of Change Control as per ichq10 change controls can be classified into following five important classes first is minor change second is measure change these two terminologies are very commonly used in pharmaceutical industry along with these two terminologies three more terminologies are used in ichq10 these are temporary change emergency change and like for like change next very frequently Asked question is when we should classify the Change Control as minor Change Control answer is when the proposed change is unlikely to have an impact on sis PQ that is safety identity strength Purity and quality of a product then we should classify the Change Control as minor Change Control these change controls does not alter the process significantly example of minor change controls are changes in the saps or any qms document for merging of content deletion of repetitive instructions alignmental changes typographical error correction with supporting data next important question when we should classify the proposed change control as major Change Control when the proper change control is likely to have an impact on sspq that is safety identity strength Purity and quality of product then we should classify the proposed change as measure change these changes are likely to have an impact on the critical attributes of the process procedures or product example of major change controls are relaxing acceptance criteria or deleting a test of raw material or drug product change in the primary packing material also shall be classified as major Change Control next question which guidelines are referred for Change Control handling in pharmaceutical industry answer is ich guideline Q10 is most commonly referred guideline for Change Control handling in pharmaceutical industry this guideline talk about qms elements such as Kappa change management system that is change control and Epicure along with these guidelines FDA quality system regulation and Preamble and Ice Age Q7 section 13 Change Control is also referred for Change Control handling in pharmaceutical industry foreign discussed question that is can we raise temperature change controls instead of plant deviation the current Thinking by regulatory authorities is there is no thing such as plan division PDA and FDA Representatives jointly stated that if you need to make a change to a procedure for a short period of time we suggest change control system to document this change instead of plan divisions we should prefer temperature change controls next one what are the categories for Change Control or where changes are required ing to Industry process flow Change Control categories can be vary commonly change controls are raised to do changes in equipment or instrument document analytical method material or vendor facility process layout or batch size next one where documented Change Control shall be kept answer is FDA recommends that required documents shall be maintained at manufacturing site or at location reasonably accessible to manufacturer and FDA required document shall be readily available for the review and copy records would be expected to be produced by the next working day or two at the latest ninth question can be stamp Change Control document as confidential before handing over it to auditor answer is yes being a manufacturer we can mark the document as confidential before producing it to auditor this can be done to assist FDA in determining whether information may be disclosed under Freedom of Information Act 10th question who shall initiate change control and who shall review Change Control the initiator shall fill the required details in Change Control form with current status or existing system then propose change justification or reason for change assessment of the change and address analysis for propose change respective department head QA and identified cross-functional team shall review the Change Control form along with the supporting data for the change proposed next important question what is responsibility of Change Control coordinator the Change Control coordinator shall review the proposed change by the initiator and enclosed documents for completeness and correctness the Change Control coordinator shall review the lease assessment provided for the proposed change and if acceptable he shall proceed the Change Control for next review stage next question what is responsibility of head QA in Change Control answer is all the change controls shall be reviewed and approved by head quality assurance head qualitation and shall review the Change Control log on monthly basis for completeness and correctness of Change Control log and take necessary actions for any overdue Change Control question number 13 whether all change controls needs to be forwarded to Regulatory Affairs for assessment answer is no all change controls shall not be forwarded to Regulatory Affairs for comments however submission or firing related change controls validation batches related change controls shall be forwarded to Regulatory Affairs for assessment as per us and Europe variation requirements next question which type of Change Control shall be forwarded to customer or qualified person for comments or approval or notification answer is product related change controls that is change in batch size addition of alternate sources of API changes in PPM shall be forwarded to the customer or qualified person for approval or notification foreign for Change Control closing answer is timeline can be proposed and approved based on the type of Change Control that is for what change proposal has been made commonly 90 days of timeline shall be preferred for minor changes like document revision however in case of changes are not implemented within the proposed timeline prior extension shall be taken and approved next important question what are the major steps for Change Control procedure Change Control procedure starts with the identification of change here we identify the current system and propose system then next stage is justification or reason for change further this proposed change is sent for review and approval procedure after approval procedure communication of approved changes is done and training is imparted to the concerned personnel next stage of Change Control procedure is implementation of approved changes and final stage for Change Control procedure is evaluation of implemented changes for their effectiveness next question how the Change Control form shall be closed answer is after completion of all proposed actions mentioned in the Change Control form initiator shall send the dually filed Change Control form along with all supporting documents to QA for review and closure upon satisfactory review of QA Change Control can be closed next question explain about Change Control timeline extension procedure answer is in case of changes are not implemented with an initially proposed timeline prior extension shall be taken and approved timeline extension shall be proposed with following three points first reason for not implementing or completing action in proposed timeline second action plan to complete actions in newly proposed timeline and third impact assessment of delay in implementation next question what is cb30 filing for change controls ing to FDA there are modded changes which include change requiring the submission of a supplement changes being affected in 30 days cb30 changes that fall into this category require a submission of a supplement that must be made to the FDA at least 30 days before the change drug product is distributed last but important question which softwares are commonly used for Change Control Management in pharmaceutical industry answer is there are many softwares available in the market for Change Control handling out of which five are mentioned here trackwise ample logic Master Control simpler qms and Azure X keep watching farm grow subscribe to channel for more videos related to pharmaceutical industry