Professional Documents
Culture Documents
ACTD……GMP…..
From the FDA Website:
https://www.fda.gov.ph/notice-on-the-adoption-of-the-pic-s-
guide-to-gmp/
Notice on the Adoption of the PIC/S Guide to GMP
Administrative Order (AO) No. 2012-008, or the rules on
quality
the “Adoption and Implementation of the Pharmaceutical
Inspection Cooperation Scheme (PIC/S) Guide for Good
Manufacturing Practice (GMP) for Medicinal Products”,
directs all drug establishments to adopt the current
version of PIC/S GMP Guide as the standard for Good
Manufacturing Practice. The AO likewise orders that all
supplements and revisions related to the PIC/S GMP
Guides shall be adopted automatically. Notwithstanding,
it is reiterated that the version of the PIC/S Guide to
GMP being implemented at this juncture is PE009-13,
which took effect on 1 January 2017, until further notice
from FDA.
PFDAC on Deficiencies
quality
PIC/S GMP Guide
1 October 2015 version 12 and January 2017
version 13 Part 1 Section 5.25 – 5.28 Starting
Materials
5.25. The purchase of starting materials is an
quality
important operation which should involve staff
who have a particular and thorough knowledge of
the suppliers.
5.26. Starting materials should only be purchased
from approved suppliers named in the relevant
specification and, where possible, directly from the
producer. It is recommended that the
specifications established by the manufacturer for
the starting materials be discussed with the
suppliers. It is of benefit that all aspects of the
production and control of the starting material in
question, including handling, labeling and
packaging requirements, as well as complaints and
rejection procedures are discussed with the
manufacturer and the supplier.
PIC/S GMP Guide
1 October 2015 version 12 and January 2017
version 13 Part 1 Section 5.25 – 5.28 Starting
Materials
quality
5.27. For each delivery, the containers
should be checked for integrity of
package and seal and for
correspondence between the delivery
note and the supplier's labels.
5.28. If one material delivery is made
up of different batches, each batch
must be considered as separate for
sampling, testing and release.
PIC/S GMP Guide
1 October 2015 /January 2017
Annex 8 Sampling of Starting and
Packaging Materials
Section 2 (Starting Materials)
quality
STARTING MATERIALS
2. The identity of a complete batch of starting
materials can normally only be ensured if
individual samples are taken from all the
containers and an identity test performed on each
sample. It is permissible to sample only a
proportion of the containers where a validated
procedure has been established to ensure that no
single container of starting material will be
incorrectly identified on its label.
PIC/S GMP Guide
1 October 2015 /January 2017
Annex 8 Sampling of Starting and
Packaging Materials
Section 3 (Starting Materials)
quality
Packaging Materials
quality
Primary Packaging
Materials
Bottles, caps, vials,
foils….
The Source/s of Materials and
Equipment
quality
Manufacturing Equipment
Ever changing
Regulations
Ever Changing Regulations
Registration Requirements
quality
For Generics:
Proof of interchangeability
(BABE/Biowaivers-Dissolution
Profiles)
Impurities
Ever Changing Regulations
GxPs
quality
Qualification,
Validation
Good Quality
Control Practice
Ever Changing Regulations
Good Quality Control
quality
Practice
Pharmacopeial
Requirements
Ever Changing Regulations
Pharmacopeial Requirements
quality
Water Purity
Residual Solvent
All USP and NF articles are subject to relevant control
of residual solvents, even when no test is specified in
the individual monograph - General Notices section
5.60.20
Joint capacity
building between the
industry and regulatory
How these challenges can
be met?
Defined reasonable and
quality
attainable time lines on
regulatory implementation
Convergence of the
mandate of the regulators and
the capability of the industry
to comply.
How these challenges
quality can be met?
Encouraging investors in
the country
Subsidies by the
government in terms of tax
incentives
Yes there are so many challenges
faced by the pharmacists and the
whole industry today to be able to
quality
comply with the current situation
but, I am sure with both the
industry’s and the regulator's
concern for public health, better
ways to face the challenges will be
made….
The pharmacists amidst the
current challenges in the
quality
Philippine Pharmaceutical
Industry together with the
other related professions can
rise up together for this is the
industry we all love and for
the health of the Filipino
people we will forever care for
Thank you very
quality