TGA Manufacturing Principles Update Adoption of PIC/S Guide to GMP - - PowerPoint PPT Presentation
TGA Manufacturing Principles Update Adoption of PIC/S Guide to GMP PE009-13 & beyond Neale Baldwin Senior GMP Inspector Manufacturing Quality Branch 22 August 2018 Overview Why adopt updates to GMP? Update Processes: EMA
Neale Baldwin Senior GMP Inspector Manufacturing Quality Branch 22 August 2018
– EMA process – PIC/S process – TGA process
– PE009-14 – PE009-??
Manufacturing Principles Update 1
TGA Manufacturing Principle Updates 2
Establish internal project team Develop gap analysis TGA consults with TIWGG on draft Gap Analysis document Comments considered and final Gap Analysis endorsed Regulatory Impact Statement (OBPR) External communications strategy developed Adoption of new Manufacturing Principles
TGA Manufacturing Principles Update 3
QUALIFICATION AND VALIDATION 1.1 All qualification and validation activities should be planned and take the life cycle of facilities, equipment, utilities, process and product into consideration.
New clause, but equivalent requirements provided in PE009-8 Annex 15§2. PLANNING FOR VALIDATION
documented in a validation master plan (VMP) or equivalent documents. Expanded planning section in PE009-13 However, this section provides additional clarification to that included within PE009-8 Clarification of existing requirements, no change to interpretation. Nil
TGA Manufacturing Principles Update 4
5.21 A process validation protocol should be prepared which defines the critical process parameters (CPP), critical quality attributes (CQA) and the associated acceptance criteria which should be based
process knowledge.
New clause, but equivalent requirements provided in PE009-8 Annex 15§6. This clause introduces the terms CPP and CQA in line with ICH Q11 terminology. While the terminology may be more prescriptive, the process of identifying critical steps (that directly influence the critical attributes of the product) and acceptance criteria remain very similar to existing methods and expectations. (Note that these concepts already exist for API manufacturers)
qualification and validation will be conducted. The protocol should be reviewed and approved. The protocol should specify critical steps and acceptance criteria. Introduction
terminology (CPP and CQA) into validation systems. Nil for some manufacturers; minor for some.
TGA Manufacturing Principles Update 5
Approved policy Documented assessment of which data will be collated and reported. Commenced amending and drafting procedures Commenced training staff in Management Reviews Initial management review meetings held. Mechanisms for resolving issues formalised and implemented Schedule for management reviews finalised. Full implementation
6 TGA Manufacturing Principles Update
Approved policy Commenced drafting procedures Risk assess/Determine list of all service providers implicated. Develop priority list for evaluation and approval of providers. Approved procedures Commenced amending/drafting new contracts Full implementation All outsourced activities approved and covered by an appropriate contract.
7 TGA Manufacturing Principles Update
September 2017
for industry
notification
November 2017
for industry
table
reporting
1 January 2018
Guide
GMP
31 June 2018 1 January 2019 Ongoing
12m Transition Period
Assess & establish Implement Full Compliance
TGA Guidance Updates
TGA Manufacturing Principles Update 8
Currently Working to Update TGA Guidance Documents
Title
Technical guidance on the interpretation of manufacturing standards: Supplier qualification Product quality review for listed Complementary Medicines On-going stability testing for listed complementary medicines Sampling and testing of Complementary Medicines Process validation for listed Complementary Medicines Guide to Interpretation of the PICS Guide to GMP - 2013 applicable to medicinal gases Guide to interpretation of the Code of GMP for the manufacture of 18FDG injections - version 2 Guidance on release for supply Manufacture of medicinal cannabis for supply under 'approved access' provisions
TGA Manufacturing Principles Update 9
10 TGA Manufacturing Principles Update
TGA Manuf acturing Principles Update 11
control the cross-contamination risks presented by the products manufactured.
– Dedicated processes, equipment and facilities; – Use of closed systems, barrier, isolator, single-use technologies; – Dust extraction, air-locks, pressure cascades; – Clean-in-place, ease of cleaning considered in process/equipment design
– Campaign operation, campaign washing, cleaning verification; – Gown management, waste management, spill management; – Detailed cleaning records and instructions, continued oversight of compliance.
TGA Manufacturing Principles Update 12
starting materials, together with their purchase and acceptance, should be documented as part of the pharmaceutical quality system.
– Supply chain traceability established and associated risks formally assessed and periodically verified. – Audits should be carried out at the manufacturers and distributors of active substances…audits should be of an appropriate duration and scope to ensure that a full and clear assessment of GMP is made. – The holder of the manufacturing authorisation shall verify such compliance either by himself/herself or through an entity acting on his/her behalf under a contract.
– formalised quality risk assessment (PI 045-1)
TGA Manufacturing Principles Update 13
TGA Manufacturing Principles Update 14
TGA Manufacturing Principles Update 15
TGA Manufacturing Principles Update 16
17 TGA Manufacturing Principles Update