Batch Disposition 5r434v
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BATCH DISPOSITION BATCH DISPOSITION REGULATION
Jakarta 14 DECEMBER 2017 Speaker: MIMI VIRLANY SYAHPUTRI, M.Sc., S.si., APT
BATCH DISPOSITION Definition • Batch disposition = product disposition = lot disposition • The documented control, status and/or usage for a Product. Examples include, without limitation, release, rejection, quarantine, hold, release for packaging, returns, destruction.
Connecting
Pharmaceutical
Knowledge
ispe.org
2
BATCH DISPOSITION Definition Applied to : Drug Products including Validation and demonstration Batches. Active Pharmaceutical Ingredients (API) including validation and demonstration batches Raw Materials (RM); API Starting Materials; Intermediates; In-Process Materials; Medical Devices; Packaging Materials; and Other Materials.
Connecting
Pharmaceutical
Knowledge
ispe.org
3
BATCH DISPOSITION Responsibility • WHO : Authorized Person The person recognized by the national regulatory authority as having the responsibility for ensuring that each batch of finished product has been manufactured, tested and approved for release in compliance with the laws and regulations in force in that country. • EU : Quality Person Responsible person for batch certification and release required at site is a basic concept of the European Pharmaceutical legislation, providing the competent national authorities a perfect recourse within a short timeframe in case of any issue with a batch certified and released by a particular QP
Connecting
Pharmaceutical
Knowledge
ispe.org
4
BATCH DISPOSITION Responsibility • US FDA : Quality Unit A group organized within an organization to promote quality in general practice • BPOM : ed/Qualified Pharmacist Personnel with adequate training and practical experiences which enable him/her to perform his/her function professionally. The head of Quality Management (Quality Assurance) should be given full authority and responsibility in all quality system /assurance duties, including:
Connecting
Pharmaceutical
Knowledge
ispe.org
5
BATCH DISPOSITION Important Aspect • Accordance to ed specification/parameter • Consider following aspect : • Safety • Efficacy • Purity • Identity • Quality
• GMP/Compliance
Connecting
Pharmaceutical
Knowledge
ispe.org
6
BATCH DISPOSITION Types GMP Disposition -
Release from Manufacturing Site to Distribution (Technical Disposition)
-
Toll manufacturing Marketing Authorization (MA) holds by other party)
-
Country that required local people to do another step of release
Market Disposition -
Released product to market
-
Performed by MA holder
Noted : GMP and Market Disposition can be done together
Connecting
Pharmaceutical
Knowledge
ispe.org
7
BATCH DISPOSITION Documents GMP Disposition -
Batch Record
-
Analytical Testing Record/CoA
-
Related form/checklist
-
Environmental Monitoring Result
-
Certificate of Conformance Manufactured as per GMP Any occurrence/deviation has been investigated and assessed
Market Disposition -
Certificate of Conformance Connecting
Pharmaceutical
Knowledge
ispe.org
8
BATCH DISPOSITION Types of Disposition
The Product Disposition shall be documented, signed (written or electronic), and dated by the Quality Team representative making the disposition decision either : •
Approved,
•
Quarantine,
•
Quarantine-Hold,
•
Acceptable for Rework/Reclaim, and
•
Rejected.
Document the actual quantity of materials being assigned the disposition
Connecting
Pharmaceutical
Knowledge
ispe.org
9
BATCH DISPOSITION Additional Aspect Quarantined-Hold, Acceptable for Rework/Reclaim or Rejected) To be verified to have been segregated from the portion of the batch or lot that is to be approved prior to the approval of the rest of the batch or lot. For Prospective Validation, validation reports must be approved prior to product release and distribution of validation batches in accordance with the established site validation requirements. For Concurrent Validation, Preliminary validation report of each batch must be approved prior to product release and distribution of validation batch in accordance with the established site validation requirements. For Contract Manufacturing Specify the requirements for approval of products produced by the contract vendor..
Connecting
Pharmaceutical
Knowledge
ispe.org
10
BATCH DISPOSITION General Manufacturing Process
Material Received
Sampling and Testing
Dispensing and Compounding
Intermediate
Disposition
Connecting
Filling and Packing
Disposition
Pharmaceutical
Knowledge
Sampling and Testing
Batch Final Status
Final Disposition
ispe.org
11
BATCH DISPOSITION Pre-requisite System System for asg a disposition to materials in accordance to regulatory :
•
Standard Operating Procedures (SOP) •
Process Validation
•
Out of Specification and Deviation
•
Material/Process Control Documents
•
Specifications,
•
Certificate of Analysis (COA),
•
Complaint and Market Action
•
Batch Records,
•
Stability Management
•
Device History Record (DHR)
•
Reprocess and Reworking
•
Certificate of Compliance.
•
Line Clearance
•
Material status indication.
•
IPC
•
Retained Sample
•
Supplier Management
•
Change Management
•
Packaging Development
Management
Connecting
Pharmaceutical
Knowledge
ispe.org
12
BATCH DISPOSITION GxP – Pharmaceutical Quality System – Batch Disposition
HA Law and Regulation
GxP
PQS
Batch Disposition
Connecting
Pharmaceutical
Knowledge
ispe.org
13
BATCH DISPOSITION GxP – Pharmaceutical Quality System – Batch Disposition •
Batch disposition = confirmation activities not quality testing activities
•
Quality must be built from beginning, not testing at the end
•
More robust GMP and PQS System = More robust in Batch Disposition Process = less chance of having bad product in the market
GMP PQS Batch Disposition
Connecting
Pharmaceutical
Knowledge
ispe.org
14
BATCH DISPOSITION GxP – Pharmaceutical Quality System – Batch Disposition •
Less robust GMP and PQS System = Vunerable in Batch Disposition Process = Micro Manage = High chance of having bad product in the market
Batch Dispostion PQS
GMP System
Connecting
Pharmaceutical
Knowledge
ispe.org
15
RAW/PACKAGING MATERIAL DISPOSITION Prerequisite System (not limited to)
• Procedure • Personnel • Culture
GMP
• • • •
Change Management Supplier Management Material Management OOS & Deviation Management
Supplier PQS Change Management Control
Lot Disposition
Connecting
Pharmaceutical
• Sampling • Testing • Disposition
Knowledge
ispe.org
16
INTERMEDIATE DISPOSITION Prerequisite System (not limited to)
• Procedure • Personnel • Culture
GMP
• • • •
Change Management Line Clearance & EM IPC OOS & Deviation Management
Supplier PQS Change Management Control
Lot Disposition
Connecting
Pharmaceutical
• Sampling • Testing • Disposition
Knowledge
ispe.org
17
FINISH PRODUCT DISPOSITION Prerequisite System (not limited to)
•Procedure •Personnel •Culture
GMP
•Change Management •Line Clearance & EM •Record Management •OOS & Deviation Management •Material Management
Supplier PQS Change Management Control
Lot Disposition
Connecting
Pharmaceutical
•Process Validation •Sampling •Testing •Disposition
Knowledge
ispe.org
18
BATCH DISPOSITION Key Principles
•
Confirmation activities
•
Sampling and testing based on sampling approach with destructive testing •
IPC
•
Process Validation
•
Holistic approach more sustainable than micro manage
•
Keep adding checking and sorting step at the end of process are not always best solution
Connecting
Pharmaceutical
Knowledge
ispe.org
19
Connecting
Pharmaceutical
Knowledge
ispe.org
Connecting
Pharmaceutical
Knowledge
ispe.org
Jakarta 14 DECEMBER 2017 Speaker: MIMI VIRLANY SYAHPUTRI, M.Sc., S.si., APT
BATCH DISPOSITION Definition • Batch disposition = product disposition = lot disposition • The documented control, status and/or usage for a Product. Examples include, without limitation, release, rejection, quarantine, hold, release for packaging, returns, destruction.
Connecting
Pharmaceutical
Knowledge
ispe.org
2
BATCH DISPOSITION Definition Applied to : Drug Products including Validation and demonstration Batches. Active Pharmaceutical Ingredients (API) including validation and demonstration batches Raw Materials (RM); API Starting Materials; Intermediates; In-Process Materials; Medical Devices; Packaging Materials; and Other Materials.
Connecting
Pharmaceutical
Knowledge
ispe.org
3
BATCH DISPOSITION Responsibility • WHO : Authorized Person The person recognized by the national regulatory authority as having the responsibility for ensuring that each batch of finished product has been manufactured, tested and approved for release in compliance with the laws and regulations in force in that country. • EU : Quality Person Responsible person for batch certification and release required at site is a basic concept of the European Pharmaceutical legislation, providing the competent national authorities a perfect recourse within a short timeframe in case of any issue with a batch certified and released by a particular QP
Connecting
Pharmaceutical
Knowledge
ispe.org
4
BATCH DISPOSITION Responsibility • US FDA : Quality Unit A group organized within an organization to promote quality in general practice • BPOM : ed/Qualified Pharmacist Personnel with adequate training and practical experiences which enable him/her to perform his/her function professionally. The head of Quality Management (Quality Assurance) should be given full authority and responsibility in all quality system /assurance duties, including:
Connecting
Pharmaceutical
Knowledge
ispe.org
5
BATCH DISPOSITION Important Aspect • Accordance to ed specification/parameter • Consider following aspect : • Safety • Efficacy • Purity • Identity • Quality
• GMP/Compliance
Connecting
Pharmaceutical
Knowledge
ispe.org
6
BATCH DISPOSITION Types GMP Disposition -
Release from Manufacturing Site to Distribution (Technical Disposition)
-
Toll manufacturing Marketing Authorization (MA) holds by other party)
-
Country that required local people to do another step of release
Market Disposition -
Released product to market
-
Performed by MA holder
Noted : GMP and Market Disposition can be done together
Connecting
Pharmaceutical
Knowledge
ispe.org
7
BATCH DISPOSITION Documents GMP Disposition -
Batch Record
-
Analytical Testing Record/CoA
-
Related form/checklist
-
Environmental Monitoring Result
-
Certificate of Conformance Manufactured as per GMP Any occurrence/deviation has been investigated and assessed
Market Disposition -
Certificate of Conformance Connecting
Pharmaceutical
Knowledge
ispe.org
8
BATCH DISPOSITION Types of Disposition
The Product Disposition shall be documented, signed (written or electronic), and dated by the Quality Team representative making the disposition decision either : •
Approved,
•
Quarantine,
•
Quarantine-Hold,
•
Acceptable for Rework/Reclaim, and
•
Rejected.
Document the actual quantity of materials being assigned the disposition
Connecting
Pharmaceutical
Knowledge
ispe.org
9
BATCH DISPOSITION Additional Aspect Quarantined-Hold, Acceptable for Rework/Reclaim or Rejected) To be verified to have been segregated from the portion of the batch or lot that is to be approved prior to the approval of the rest of the batch or lot. For Prospective Validation, validation reports must be approved prior to product release and distribution of validation batches in accordance with the established site validation requirements. For Concurrent Validation, Preliminary validation report of each batch must be approved prior to product release and distribution of validation batch in accordance with the established site validation requirements. For Contract Manufacturing Specify the requirements for approval of products produced by the contract vendor..
Connecting
Pharmaceutical
Knowledge
ispe.org
10
BATCH DISPOSITION General Manufacturing Process
Material Received
Sampling and Testing
Dispensing and Compounding
Intermediate
Disposition
Connecting
Filling and Packing
Disposition
Pharmaceutical
Knowledge
Sampling and Testing
Batch Final Status
Final Disposition
ispe.org
11
BATCH DISPOSITION Pre-requisite System System for asg a disposition to materials in accordance to regulatory :
•
Standard Operating Procedures (SOP) •
Process Validation
•
Out of Specification and Deviation
•
Material/Process Control Documents
•
Specifications,
•
Certificate of Analysis (COA),
•
Complaint and Market Action
•
Batch Records,
•
Stability Management
•
Device History Record (DHR)
•
Reprocess and Reworking
•
Certificate of Compliance.
•
Line Clearance
•
Material status indication.
•
IPC
•
Retained Sample
•
Supplier Management
•
Change Management
•
Packaging Development
Management
Connecting
Pharmaceutical
Knowledge
ispe.org
12
BATCH DISPOSITION GxP – Pharmaceutical Quality System – Batch Disposition
HA Law and Regulation
GxP
PQS
Batch Disposition
Connecting
Pharmaceutical
Knowledge
ispe.org
13
BATCH DISPOSITION GxP – Pharmaceutical Quality System – Batch Disposition •
Batch disposition = confirmation activities not quality testing activities
•
Quality must be built from beginning, not testing at the end
•
More robust GMP and PQS System = More robust in Batch Disposition Process = less chance of having bad product in the market
GMP PQS Batch Disposition
Connecting
Pharmaceutical
Knowledge
ispe.org
14
BATCH DISPOSITION GxP – Pharmaceutical Quality System – Batch Disposition •
Less robust GMP and PQS System = Vunerable in Batch Disposition Process = Micro Manage = High chance of having bad product in the market
Batch Dispostion PQS
GMP System
Connecting
Pharmaceutical
Knowledge
ispe.org
15
RAW/PACKAGING MATERIAL DISPOSITION Prerequisite System (not limited to)
• Procedure • Personnel • Culture
GMP
• • • •
Change Management Supplier Management Material Management OOS & Deviation Management
Supplier PQS Change Management Control
Lot Disposition
Connecting
Pharmaceutical
• Sampling • Testing • Disposition
Knowledge
ispe.org
16
INTERMEDIATE DISPOSITION Prerequisite System (not limited to)
• Procedure • Personnel • Culture
GMP
• • • •
Change Management Line Clearance & EM IPC OOS & Deviation Management
Supplier PQS Change Management Control
Lot Disposition
Connecting
Pharmaceutical
• Sampling • Testing • Disposition
Knowledge
ispe.org
17
FINISH PRODUCT DISPOSITION Prerequisite System (not limited to)
•Procedure •Personnel •Culture
GMP
•Change Management •Line Clearance & EM •Record Management •OOS & Deviation Management •Material Management
Supplier PQS Change Management Control
Lot Disposition
Connecting
Pharmaceutical
•Process Validation •Sampling •Testing •Disposition
Knowledge
ispe.org
18
BATCH DISPOSITION Key Principles
•
Confirmation activities
•
Sampling and testing based on sampling approach with destructive testing •
IPC
•
Process Validation
•
Holistic approach more sustainable than micro manage
•
Keep adding checking and sorting step at the end of process are not always best solution
Connecting
Pharmaceutical
Knowledge
ispe.org
19
Connecting
Pharmaceutical
Knowledge
ispe.org
Connecting
Pharmaceutical
Knowledge
ispe.org
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