Batch Review And Batch Release.pptx

This content includes batch review and batch release of pharmaceutical product and also contain a case study of the pharmaceutical industry.

1. M.Pharm Sem 1 Presentation Batch Review And Batch Release SUBJECT -Quality Management System Bubal Knowledge City, MET’s Institute of Pharmacy, Adgaon , Nashik , 422003. Maharashtra, India Presented By- Mr.Abhishek R. Jadhav (QAT) SEM I ROLL NO. 06 Guided By- Dr.S.P.Ahirrao Academic Year-2021-22

2. Content Batch review and Batch release Concept of IPQC Line clearance Case Study

3. Acc. to 21 CFR Part 211.188; For each batch of drug product produced, Batch Production and Control Records must be kept, and they must contain all important information on the batch's production and control. These records must include the following items: - Batch review and Batch release

4. Requirement The following items must be included in these records: Dates. The names of the principal pieces of equipment and lines that were employed. Each batch of a component or in-process material used must be identified specifically. Component weights and measurements used during processing. Results of in-process and laboratory controls. Before and after use, inspect the packing and labeling area. At the relevant stages of processing, a statement of the actual yield and a statement of the percentage of the theoretical yield. Labeling control records in their entirety, including specimens or copies of all labeling utilised . Containers and closures for pharmaceutical products.

5. Objective  To ensure that there is enough evidence to show that the batch is of acceptable quality and was produced in a controlled environment. Significance To ensure that there is enough evidence to show that the batch is of acceptable quality and was produced in a controlled environment.

6. GMP requirement ICH Q7 Responsibilities of the Quality Unit- All quality-related papers should be reviewed and approved by the quality unit. The main responsibilities of the independent quality unit are; All APIs are either released or rejected. Release or rejection of intermediates for usage outside the manufacturing company's control Putting in place a mechanism for releasing or rejecting raw materials, intermediates, packing, and labeling materials.

7. Approval of all specifications and production master instructions Making sure that audits are performed. Responsibility for Production Activities- Reviewing and verifying that all production batch records are completed and signed.

8. . Assuring that all production variations are reported and analyzed, as well as that important deviation are examined and the results documented. Assuring that production facilities are clean and disinfected as needed. Assuring that the buildings, equipment, and records are preserved in good working order.

9. As per ICH Batch Review Before a batch is released or distributed, written procedures should be established and followed for the evaluation and approval of batch production and laboratory control records, including packaging and labeling, to determine conformity of the intermediate or API with defined requirements. Before an API batch is produced or distributed, the quality unit should evaluate and approve the batch production and laboratory control records of important process steps. Noncritical process step production and laboratory control records can be checked by certified production people or other units following procedures established by the quality unit. As part of the batch record review, all deviations, investigations, and OOS reports should be checked before releasing a batch. The quality unit may delegate quality assurance to the production unit.

10. Production record review Before a batch is issued or distributed, the quality control unit must evaluate and approve all drug product production and control records, including those for packaging and labeling, to ensure compliance with all established, approved written procedures. Any unexplained discrepancy or failure of a batch or any of its components to satisfy any of its specifications, whether or not the batch has been dispersed, must be properly scrutinized. Other batches of the same prescription product, as well as other drug products that may have been linked to the specific failure or discrepancy, will be investigated.

11. Responsibility Of QC Unit as per 21 CFR 211.22 Section 211.22: Quality Control Unit Responsibilities All components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products must be approved or rejected by a quality control unit with the responsibility and authority to do so. The quality control unit is in charge of approving or rejecting drug items that have been manufactured, processed, packed, or held under contract by a third party. The quality control unit's responsibilities and processes must be written down, and these written procedures must be followed.

12. Authority to conduct a review of production records to ensure that no mistakes have happened. If mistakes have occurred, they have been thoroughly examined.

13. Effective batch review and batch release For an effective, consistent, and systematic review, the following documents are required: Production, packaging, labelling, laboratory testing, and other aspects of batch record review should be covered by the SOP. BPR Review Checklist - to guarantee that the BPR review is comprehensive and documented. Also we can use Corrections Sheet

14. SOP for batch record review Describes the purpose/scope of the BPR Review Describes the BPR Review’s aim and scope. It’s not just about identifying exceptions (mistakes, oversights, illegible input, and so on) and taking action. Release authority/responsibility: QA head, Authorised person, or any other appropriately qualified person Authorised Describes the importance of a thorough and correct review of BPR. Its purpose is to ensure that the records are clear and correct, as well as to provide evidence that the batch was created and regulated according to internal processes and cGMPs .

15. SOP for Batch Record Review The following should be included in the batch record review SOP: Production and Quality Control Specifications Recommendations and corrections from the reviewers. During the evaluation, the reviewer looks for typos, missing entries, or failures to follow GDP. Describe the components of a “Corrections Sheet,” which a QA reviewer can use to record corrections discovered during a review. Verification of source data, where possible, to ensure that the Record’s contents are correct. – For instance, a material weighing print, a temperature record, a dispensing record, and so on. If critical information is missing, the SOP must specify how and when a QA reviewer should be notified to begin and investigate deviations.

16. SOP for Batch Record Review To ensure that the product is of high quality and consistent, review and verify the following. Controlling essential stages and other variables that affect quality ensures this. Temperature, time, flow rates, pressures, and other discrete input settings or output measurements on the process equipment are all measured using a process meter (PP). Critical Process Parameters (CPPs) Critical Quality Attributes (CQAs) are process parameters that have an impact on quality attributes. In terms of quality standards and process control- The findings of physical, chemical, or microbiological tests are within the acceptable range.

17. SOP for Batch Record Review Investigating critical deviations or a batch of intermediate or API that failed to satisfy specifications. Other batches that may have been linked to the specific failure or deviation should be investigated as well. Before the batch is issued, all deviation, investigation, and OOS report should be examined as part of the batch record review.

18. IN PROCESS QUALITY CONTROL Definition IPQC is Concerned with providing a detailed and precise explanation of the procedure to be followed from the receiving of raw materials through the release of the finished product. During production, checks are carried out to monitor and, if necessary, change the process to guarantee that the product meets its criteria. Environmental or equipment control can also be considered a part of process control. In most cases, in-process controls are carried out in the manufacturing area. The implementation of such in-process controls should not have a detrimental impact on the product's or another product's quality.

19. Objective To reduce the number of human errors. Describe the technique to be used in a precise, exact, and defined manner. To detect faults if and when they happen. Human-initiated corrective action. Assign responsibilities to the employees who are involved in the process's functioning. To ensure that manufacturing and packing operations are carried out by specified routes and procedures. Strictly adhered to. Any irregularity should be detected immediately, and the type of action required to fix the problem should be indicated.

20. Line clearance Definition- Line clearance is a structured procedure for ensuring that equipment and work area are free from products, documents, and material from the previous process that is not required for the next schedule, and equipment is clean and ready for the next schedule process. Filling/packing areas are immediately closed and free from all previous filled/packed products. Rejected packing material should also be removed. Procedure for line clearance-

21. If the filling/packing area equipment has been idle for an extended period then it should be re-inspected. After completion of all procedures, this will be checked and signed by the supervisor. Line clearance will be recorded in a suitable format (attached with sop)and this will form a part of the production record.

22. CASE STUDY Introduction GlaxoSmithKline (GSK) is a global healthcare company based on science that develops and researches a wide range of innovative medicines and brands. GSK's goal is to consistently deliver outstanding quality, service, and value to patients and consumers with zero defects, with manufacturing facilities in over 70 locations around the world. Several packaging lines process upwards of 10,000 batches per year, with each batch record including over 1,000 manual record entries, totaling more than 10 million manual record entries each year. The preparation and evaluation period for each batch was ten days.

23. Challenges As part of a continuous improvement approach, GSK sought to examine the structure of its batch production record and associated workflows. Reduced batch review time usually means faster batch cycle time, which means increased throughput at the manufacturing facility and a shorter cash-to-cash cycle time. Because of its interaction with other technologies, such as Aspen InfoPlus.21, part of the Aspen AIoT Hub, and GSK's existing plant automation software, AspenTech was chosen for this process (DCS). The pilot project was a huge success, cutting order preparation time by 95% and record review time by more than 50%. As the batch travels through the manufacturing process, Aspen Production Execution Manager creates and maintains electronic records automatically, eliminating manual effort while keeping the SOP visible.

24. Manual Process Slows Batch Release Time GSK is no exception to the pharmaceutical industry's inherent complexity. Many of the company's procedures necessitate operators performing several manual data entries regularly, in addition to other production activities. For example, the Multi-Dose Powder Inhaler (MDPI) Assembly & Pack at Ware processes 10 million manual data inputs per year, requiring 3,000 man-hours per year to capture Process Equipment Logbook (PEL) events. Over time, the batch record has required more and more information. This vital but bloated documentation hindered manual manufacturing operations, and the paper trail caused quality investigations to take longer than they should have.

25. Conquering the Complexity GSK began with a three-site pilot project: device assembly and packing at two sites in two countries, as well as solid dosage manufacture at a third site. GSK developed a core committee to communicate with the three sites, set expectations, and monitor outcomes. The outcomes have been spectacular. As the batch travels through the manufacturing process, Aspen Production Execution Manager creates and maintains electronic records automatically, eliminating manual effort while keeping the SOP visible. A detailed examination of the audit process also revealed that GSK could drastically reduce the amount of data needed to support a batch. Order preparation cycle time has been decreased by 95%, and record review time has been reduced by 50%, allowing operators to work significantly faster than before.

26. Reference https://www.aspentech.com/-/media/aspentech/home/resources/case-study/pdfs/at-07380-gsk_case-study_updates-0916.pdf https://www.ich.org/page/quality-guidelines https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.188 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=211.22

27. THANK YOU