The document summarizes some of the key challenges facing pharmacists and the Philippine pharmaceutical industry. It identifies challenges related to the sources of materials and equipment, regulatory harmonization, the regulatory body, and developing a healthy business ecosystem. It discusses issues around sourcing active pharmaceutical ingredients, equipment qualification, and evolving regulatory standards. Potential solutions proposed include developing joint qualification schemes, regulatory capacity building, reasonable implementation timelines, and encouraging investment. The overall aim is to ensure a sustainable supply of safe, quality generic medicines for Filipinos.

1. quality
"The Pharmacists amidst
the Current Challenges in
the Philippine
Pharmaceutical Industry "
2019 PPhA National Convention
Date: May 3, 2019
SMX Convention Center, Davao

2. quality Challenges “WE” face
The Source/s of Materials
and Equipment
The Harmonization
The Regulatory Body
Healthy Filipino Business
Ecosystem

3. quality Disclaimer
The knowledge and
information, in this
presentation are based on
the presentor's experiences,
and references cited, and
represent the views of the
presentor for the purpose of
knowledge sharing

4. quality Challenges “WE” face
The Source/s of Materials
and Equipment
The Harmonization
The Regulatory Body
Healthy Filipino Business
Ecosystem

5. quality The Source/s of Materials and
Equipment
 API – Active
Pharmaceutical Ingredients
 BPE – Bulk Pharmaceutical
Excipients
ACTD……GMP…..

6. quality 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
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.

7. quality PFDAC on Deficiencies

8. 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
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.

9. 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 version 12 and January 2017
version 13 Part 1 Section 5.25 – 5.28 Starting
Materials

10. quality
PIC/S GMP Guide
1 October 2015 /January 2017
Annex 8 Sampling of Starting and
Packaging Materials
Section 2 (Starting Materials)
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.

11. quality PIC/S GMP Guide
1 October 2015 /January 2017
Annex 8 Sampling of Starting and
Packaging Materials
Section 3 (Starting Materials)
It is improbable that a procedure could be
satisfactorily validated for:
 starting materials supplied by
intermediaries such as brokers where the
source of manufacture is unknown or not
audited;
 starting materials for use in parenteral
products.

12. quality The Source/s of Materials and
Equipment
 Packaging Materials
PIC/S GMP Guide 1 October 2015 (version 12
and January 2017 version 13 Part 1 Section 5.40
Packaging Materials
The purchase, handling and control of
primary and printed packaging materials
should be accorded attention similar to that
given to starting materials.

13. quality The Source/s of Materials and
Equipment
 Packaging Materials
 Primary Packaging
Materials
 Bottles, caps, vials,
foils….

14. quality The Source/s of Materials and
Equipment
 Manufacturing Equipment
 Blister Machines, Fluid
bed driers, Tableting
Machines, Encapsulating
Machines, ….

15. quality The Source/s of Materials and
Equipment
 QC/Laboratory Equipment
 HPLC, GC, AAS, IR,
ICP, ….

16. quality Challenges “WE” face
The Source/s of Materials
and Equipment
The Harmonization
The Regulatory Body
Healthy Filipino Business
Ecosystem

17. quality
The Harmonization
 Ever changing
Regulations

18. quality Ever Changing Regulations
Registration Requirements
For Generics:
 Proof of interchangeability
(BABE/Biowaivers-Dissolution
Profiles)
 Impurities

19. quality Ever Changing Regulations
Good Quality
Control Practice
Qualification,
Validation
 GxPs

20. quality Ever Changing Regulations
 Good Quality Control
Practice
Pharmacopeial
Requirements

21. quality Ever Changing Regulations
 Pharmacopeial Requirements
 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
 Elemental Impurities – USP
 Specifies limits for the amounts of elemental
impurities in drug products.
 However elemental impurity levels present in drug
substances and excipients must be known,
documented, and made available upon request

22. quality Challenges “WE” face
The Source/s of Materials
and Equipment
The Harmonization
The Regulatory Body
Healthy Filipino Business
Ecosystem

23. quality
From the Presentation to Philippine Chamber of Pharmaceutical Industry
28 Oct 2015
A/Prof John CW Lim
Executive Director, CoRE, Duke-NUS Graduate Medical School
Deputy Director of Medical Services (IRM), MOH Singapore
– Issues on the competencies of
national regulators and industry
regulatory officers
– Issues on the appropriate
communication between regulators
and industry
– Issues on the harmonisation of
regulatory procedures with many
country specific requirements
Issues identified by the
Pharmaceutical Industries:

24. quality Challenges “WE” face
The Source/s of Materials
and Equipment
The Harmonization
The Regulatory Body
Healthy Filipino Business
Ecosystem

25. quality
Philippines is not a
pharmaceutical hub hence it is
important that we are able to
partner with reputable
companies that can give us
resources that we need to
create our value chain.
Healthy Business
Ecosystem………….

26. quality
We need to realize that we may not be the
biggest pharmaceutical market in the
world but we are the second biggest in
ASEAN. Both our population and
economic growth are attractive for other
investors to come in. We need to
LEVERAGE on this as a country. The
sooner we realise that protecting our
country’s interests on medicines as part
of our self sufficiency on essential goods
and also a part of contributing to a robust
economy the better for our people.
Healthy Business
Ecosystem………….

27. quality
"Filipino First” - We need to start
looking into becoming net
producer vs net consumer.
Instead of outwardly looking, it
should be inward where we
enhance not only what we
produce but also enhancing the
talents of people inside the
Philippines.
Healthy Business
Ecosystem………….

28. quality
Healthy Business Ecosystem is
important so that we can keep our
competitive edge. It boils down to
attracting investors in ASEAN to
choose Philippines as the country of
choice for their investments.
Business community will always play
at arms-length if they see that
business policies are not favorable to
them or they find other countries
more favorable than Philippines.
Healthy Business
Ecosystem………….

29. quality
Providing quality, safe
and affordable generic
medicines to the
Filipinos
But the ultimate
Challenge………….

30. quality How these challenges
can be met?
Group APIs/BPEs
qualification scheme
Joint capacity
building between the
industry and regulatory

31. quality How these challenges can
be met?
Defined reasonable and
attainable time lines on
regulatory implementation
Convergence of the
mandate of the regulators and
the capability of the industry
to comply.

32. quality
How these challenges
can be met?
Encouraging investors in
the country
Subsidies by the
government in terms of tax
incentives

33. quality Yes there are so many challenges
faced by the pharmacists and the
whole industry today to be able to
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….

34. quality The pharmacists amidst the
current challenges in the
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

35. quality
Thank you very
much and good
day to all