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Annex10a - Asean Guideline On Process Validation - Presentation (1 - July - 2003) - Adopted
Annex10a - Asean Guideline On Process Validation - Presentation (1 - July - 2003) - Adopted
Annex10a - Asean Guideline On Process Validation - Presentation (1 - July - 2003) - Adopted
Process Validation
Objectives of Presentation
To provide update on outstanding
issues arising from last meeting
To discuss proposed changes (for
fine-tuning)
To seek concurrence on proposed
amendments and adoption as the
final guideline
Outline of Presentation
Background
Proposed Changes & Rationale
Industrys feedback and Comments by
member countries
Discussion
Background
Part of ACTD and ICH CTD
6th PPWG meeting - Adopted as Asean
working guideline
Follow up action consider
a) the use of retrospective data as a basis for
validation requirement for site changes, if
equivalent equipment and process is
maintained
b) to review the applicability of EU Validation
Scheme for the ACTD
Revised guideline was sent to other member
countries for comment in mid May
Standard commitment:
Commitment (a)
To undertake that 3 consecutive full production
batches are successfully validated before the
product is marketed and to submit the report to
the DRA upon request within a specified time
frame or to make the information from these
studies available post authorisation for
verification by DRA , according to the national
procedure.
procedure
Other feedback
Industry
Concurrent Validations for generic
products
Prospective validation is preferred.
Member countries
Laos, Malaysia agreeable to the
changes
Other feedback
Member countries (contd)
Indonesia `A validated manufacturing process is one that has been proven to
do that (what) it purports or is presented to do .
`commercial dosage form to be changed to `finished product
`commercial scale batches to be changed to `production scale
batches
[sec 5 (b)] A summary of the critical processes and control variable
to be studied during validation and justification for their
selection.
[sec 8] change of new equipment
[sec 6 (a)] Summary, (including approval signature from authorised
person/persons)
[sec 6 (k)]Evaluation of (data including comparison against )
acceptance criteria
[sec 6 (m)] Results and discussion to be deleted as it is already
Other feedback
Member countries (contd)
Thailand Agreeable to proposed editorial changes to section 2
Agreed to waive summary but retain validation protocol
for Option 1.
Validation report to be discussed in the meeting
Prefer the original submission requirement under option
2 i.e. development pharmaceutics report, Validation
report on 1 pilot batch and (vs `or in revised guideline)
Validation scheme.
Prefer the original commitment (a) stipulated under
option 2 I.e to submit the report upon request
Agreeable to deletion of commitment (b)
Other feedback
Member countries (contd)
Philippines To revise the commitment (a) to
To undertake that 3 consecutive full production batches are
successfully validated (post authorisation) before the
product is marketed and to submit the report to the DRA
within a specified time frame or to make the information
from these studies available post authorisation for
verification by DRA, according to the national procedure
(while the product is marketed).
To revise statement under option 3.
Under certain circumstance where validation documents
may not form part of the pre-approval dossiers, the DRA
may request for Validation Report or Validation Scheme.
applicant should submit all the validation
Other feedback
Member countries (contd)
Philippines To revise the statement under sec on concurrent validation
In the case of orphan drugs, (For products where ) when the
number of production batches per year is expected to be low,
concurrent validation is acceptable.
Modified :
In the case of orphan drugs, when the number of production batches ..
concurrent validation is acceptable. The applicant should seek prior
consent on this from DRA before submitting the application to register
any such drug product that uses concurrent validation approach.
To delete the term `Industrial Scale Batch from the glossary as it is
not mentioned in the guidelines.
`Industrial Scale Batch to be changed to `production scale batches
`Laboratory scale batch to be deleted, `Finished pdt to be
incorporated
Summary
Agreement to
Summary