Current Continuous Process Validation Program (ccvp) Following FDA 2011 Guidelines

Transcription

1 Current Continuous Process Validation Program (ccvp) Following FDA 2011 Guidelines Presented By Víctor J. Hernández Sustaining Engineering, Sr. Validation/Project Eng. III EMD Millipore Corporation

2 CURRENT CONTINUOS PROCESS VALIDATION PROGRAM (ccpvp) FOLLOWING FDA CURRENT GUIDELINES AGENDA A. Research Actual Corporate PVP B. Site Actual & New PVP Development C. Site and Corporate Negotiations D. Supply Chain Communications E. Case Study

3 Prerequisites To Understand This Course FDA Process Validation Guidelines (Jan 2011) ISPE Risk Management (Oct 2011) ASTM 2500E-07 (Aug 2007) current ICH Q8, Q9 and Q10.

4 Review Actual Corporate and Division PVP Requirements 1.0 Actual Corporate PVP Requirements 1.1 Policies V&Q (Validation Plans, Commissioning, IQ, OQ, PQ and PV) Cleaning Validation (CIP & SIP). 1.2 Followed Guidelines (i.e. ISPE etc.). 2.0 Division 2.1 Guidelines. 2.2 SOP s, MP s and TM s.

5 Actual Site Validation Program/Draft New Documents 3.0 Verify Site Actual PVP 3.1 Design, Develop, Generate and Approve a Requalification Assessment Plan Purpose Scope Equipment List and Priority, Requalification Assessment Plan (RAP) Determination of Requirement to Requalify.

6 Actual Site Current Validation Program/Draft New Documents (Continued) Determination of Requalification Priority Weighting and Totals Requalification Priority and Execution Plan Equipment Requalification Plan Maintenance. 3.2 Final Requalification Report. 3.3 Processes Validation Life Cycles.

7 Actual Site Current Validation Program/Draft New Documents (Continued) 3.4 Verify and review Site SOP s, MP s, TM s and SVMP (Site Master Validation Plan) and All current Validation Plans. 3.5 Verify and Review Customer Audit, Complaint, Vendor/Supplier Certification Programs. 3.6 Verify and Review Annual Product Review and Perform GAP Analyses from Previous Program.

8 Actual Site Current Validation Program/Draft New Documents (Continued) 3.7 Verify and Review QAP (Quality Assurance Plan) Define New Approach, Trends, Guidelines and Develop Strategy to Implement Changes Define All Process Controls and Acceptance Criteria (For All Units to Know).

9 Actual Site Current Validation Program/Draft New Documents (Continued) 3.7.3Verify all the QA Documentation (Manual and Automated) that will be affected with the changes Store all documents to wait for Corporate new PVP approval.

10 Disciplines Involved 4.0 The Following Site Disciplines Are Required to Assist in the for the New PVP 4.1 R & D. 4.2 Engineering. 4.3 Facilities & Utilities. 4.4 Maintenance. 4.5 Operations (Manufacturing & Packaging). 4.6 Materials (Raw Materials & Components). 4.7 Planning/Warehouse.

11 Disciplines Involved (Continued) 4.8 QC & QA (Quality Documentation System). 4.9 Process Engineering & QE Regulatory Affairs (RA).

12 New Site PVP 5.0 Site new PVP 5.1 Design, Develop and Generate the new PVP to present to Corporate. 5.2 Assure that new PVP complies with Reviewed QAP and New Val Approaches. 5.3 Perform experimental project with new PVP approaches. Select a case study to demonstrate feasibility of the new PVP. 5.4 Communicate and train Site Management & Disciplines.

13 New Site PVP (Continued) 5.5 Obtain unanimous consensus for acceptance prior to present to Corporate. 5.6 Interim approve but do not implement before Corporate submittal. 5.7 Create a Corporate submittal team ( Eng., Validation, Operations and QA).

14 Establish Site/Corporate Negotiations 6.0 Negotiation Plan 6.1 Site RA, QA, Engineering, Operation and Validation representatives present Corporate the new PVP and new approaches used to develop it. 6.2 Site QA Manager and Validation SME and Manager (speakers) present case study with back up from all disciplines with all the advantages of the new PVP (RA, Op s, Process Control, QA, Resourcing and $$$). 6.3 Present approach of Division and Sites advantages and how new PVP will standardize Validation.

15 Just To Remind You (Concepts) Validation is proof of knowledge and control Prove today that what you did yesterday you can do tomorrow

16 Concepts (Continued) Successful validation depicts a process which has consistent characteristics and is in a state of control. Validation is way of assuringquality to our customers. Validation demonstrates that a process can consistently perform as expected. Also validation can lead to quality improvementand optimization.

17 Good Business... experience with the application of validation principles for the introduction of a new, current or a major process change clearly indicates the business value, usefulness and need for the universal application of validation practices...

18 Good Validation Approaches A process with consistent quality attributes and operating ranges. Fewer customer complaints. Enhanced reputation. Marketing advantage. Better communication between functional areas. Reduced costs.

19 Cost Reduction Reduced in-process and final product sampling and testing. Fewer reworks, abnormalities, rejects or failures. Less re-sampling, re-testing and investigative down-time. More rapidand reliable start-up of new equipment or process improvements. Quick new product approval. Improved efficiency and flexibility.

20 Cost Reduction Spending $1.00to preventa problem before it occurs saves. Spending $10.00to fixa problem after it happens. Or $100.00to repairthe damage after it reaches the customer.

21 CASE STUDY Our PV Case Studies

22 VIRESOLVE & DURAPORE We had two (2) Facilities remodeling Projects involving our main products. These 2 project followed the current new approaches based on the current FDA Process Validation Guidelines (Jan 2011), ISPE Risk Management (Oct 2011), ASTM 2500E-07 (Aug 2007) and current ICH Q8, Q9 and Q10.

23 CASE STUDY VIREOLVE

24 CASE STUDY DURAPORE

25 FDA Process Validation Guidelines (Jan 2011) The use of these guidelines following the stages, gave us the opportunity to reduce documentation generation, approval time and execution. By collecting product data since the design phase (QbD) and continue with the process development phase and qualification period using product and following the Risk Assessment Guidelines, Validation Time was lowered (as well as costs) and many of the redundant activities (i.e. Commissioning vs IQ/OQ) and the process validations (PQ vs PV vs Prod. V) were joined together (Stage 1 and 2) and a very exhaustive statistical data gathering and evaluation gave us the opportunity to provide a robust Validation Package and further Continuous Validation Program (Stage 3) that helped us to provide the facilities, utilities, process and quality to have the product in the market on time as well as to decrease or back orders and increase our yields.

26 CASE STUDY The use of these guidelines provided a stunning project time and costs reduction (thus, product back on market before the scheduled time). The experience of separating different validation projects that were performed parallel, for new Facilities and Utilities, New, Relocated, Retrofitted Equipment (FAT leveraging IQ s, OQ/DOE s and PQ s), Process Optimizations and Line Performance Qualifications in record time, expedited the RTM (Return to Manufacturing) time. This, because of the use of new approaches.

27 Corporate Acceptance Negotiations 7.0 Establish Negotiation Plan 7.1 Site RA, QA, Engineering, Operations and Validation representatives present Corporate the new PVP and new approaches used to develop it. 7.2 Site QA Manager and Validation SME and Manager should be the main speakers and should present the case study with back up from all the disciplines stating all the advantages of the new PVP (Regulatory, Operationally, Process Control, Quality, Resourcing and $$$$$$) with the obtained case study evidence. 7.3 Present approach of Division and Sites advantages and how new PVP will standardize these.

28 Implementation 8.0 If Corporate Accepts 8.1 Create a transitional committee Determine transitional period Provide the start date for the new PVP Provide the time to finish previous PVP activities that were in calendar Provide a schedule for the implementation of the new PVP. 8.2 Site QA Manager and Validation SME and Manager should be the group that will implement the new Plan. 8.3 The Quality Documentation System should start to develop at this time the transition to new templates for all the affected documentation of this new plan.

29 Implementation (Continued) 8.4 Open Stored Documents Use these for training purposes and use this time to receive comments from all trainees in order to scrutinize opinions and possible additions to the documents prior to approval When all the required personnel is trained, then proceed to approve the documents. 8.5 Implement the New PVP QA shall implement all the impacted internal areas like QC, QDS, Auditors etc. with the new requirements of the PVP Vendors, Suppliers and Clients shall be provided with non-proprietary information about the changes done to policies, guidelines and management procedures affected.

30 Implementation (Continued) A continuous communication channel has to be implemented in order to have documents to talk to each other as well as all the disciplines involved shall take ownership of each Process Validation Activities determined by RAP.

31 Q & A How do we maintain the Validated State? It s has been an HONOR to address All of YOU Today Here for the first time in my Country!!!! THX