Republic of the Philippines
Department of Health
FOOD AND DRUG ADMlNISTRATION
FDA CIRCULAR 117 SEP 2018
No. 2018 - ~ 19
SUBJECT: Risk Management Plan (RMP) for Drng Establishments
l. BACKGROUND/RATIONALE
Republic Act (R.A.) No. 9711, otherwise known as the "Food and Drug
Administration (FDA) Act of 2009" was issued to (a) enhance FDA 's regulatory
capacity and strengthen its capability with regard to the inspection, licensing and
monitoring of establishments and the registration and monitoring of health products.
and (b) ensure FDA 's monitoring and regulatory coverage over establishments and
products Linder its jurisdictions (such as drug establishments and their drug products).
As provided under Book I, Article VIr, Section 4 (h) of the Implementing
Rules and Regulations of R.A. No. 9711. FDA has the power to mandate. order.
review, and implement a Risk Management Plan (RMP) on any health product for
conformance with FDA standards. Also, Book L Article II, A, Section 2 (I) requires
all concerned to implement RMPs which is a requirement for the issuance of
appropriate authorization. More recently, Administrative Order No. 2014-0034.
"Rules and Regulations on the Licensing of Establishments Engaged in the
Manufacture, Conduct of Clinical Trial, Distribution, Importation, Exportation, and
Retailing of Drug Products, and Issuance of Other Related Authorizations, and
Administrative Order No. 2016-0003, "Guidelines on the Unified Licensing
Requirements and Procedures of the Food and Drug Administration (FDA)", formally
mandates all drug establishments to have an RMP.
RMP is defined as a set of health product vigilance activities and interventions
designed to identify, characterize, prevent or minimize risks to health products, and
the assessment of effectiveness of those interventions. The implementation of an RMP
as a requirement for drug establishments shall result in the coordinated and
economical applications of resources to minimize, monitor, and control the
probability and/or impact of risks to drug products with respect to their safety.
efficacy, and quality.
2. OBJECTIVE
The objective of this FDA Circular is to provide guidance on the preparation
of an RMP as part of the FDA 's requirements for the issuance of a License to Operate
(LTO).
3. SCOPE
This FDA Circular shall apply to all drug establishments, namely but not
limited to(]) Distributors, (2) Drugstores/ Pharmacies/ Boticas including hospital and
institutional pharmacies. (3), Retail Outler for Non-Prescription Drugs (RONPDs), (4)
Civic Drive, Fil invest City, Alabang 1781 Muntinlupa, Philippines
Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: [Link] Email: info@[Link]
Sponsors, and Contract Research Organizations (CROs). However, manufacturers are
required to comply with the standards of Pharmaceutical Inspection Co-Operation
Scheme (PIC/S).
4. GUIDELINES
[Link] RMP for Establishments
All RMP for establishments must contain the following minimum sections: (1)
Introduction, (2) Risk Identification, (3) Risk Minimization, (4) Risk Communication,
and (5) Risk Monitoring and Management Evaluation.
4. 1.1 Introduction
(a) Internal Environment. The internal environment of the drug establishment
must be described in this section, as it sets the basis on how risks are
viewed and addressed. The following information must be included in this
section:
• A brief description of the establishment, its objectives, mission and
vision;
• A brief description/illustration of the organization - the different
departments/divisions, head officers (and their respective functions and
responsibiJ ities/duties;
• The risk management officer/team, where applicable;
• Other attached establishments/institutions critical to the functioning of
the establishment and their relation to the drug establishment, functions
and responsibilities/duties; and,
• Contact information of responsible officers during and beyond office
hours.
(b) Risk Management Approach. A brief description of the overall risk
management approach of the drug establishment must be provided in this
section: the risk management processes, the personnel involved, the
periodic reporting and monthly procedures to be performed, among others.
( c) Risk Management Objectives. Once the internal environment has been
established, the specific objectives of the [Link] should be set. In general,
the objectives set must be to ensure the safety, efficacy, and quality of the
drug products the establishment engage with in order to protect public
health.
( d) Data Lock Point. The timeframe to which the RMP is expected to be valid
should be indicated in [Link] section.
4.1.2 Risk Identification
Risk identification consists of the identification and assessment of risks that may
adversely affect the set objectives stated. In the preparation of risk identification,
the following must be prepared:
Page 2 of 4
(a) Risk universe containing all identified risks;
(b) Assessment of the risks based on their (i) significance and (ii) Likelihood of
occurrence made using accepted risk management tools to enable
establishments to identify priority risks to manage within a given data lock
point; and,
(c) Tabulated summary risk register containing:
i. The priority risks;
ii. The specific objectives under which the priority risks belongs; and,
iii Naming convention for each priority risk
For risks not currently known, planned activities must be set by the drug
establishment to identify them.
4.1.3 Risk Minimization
For each priority risk, the appropriate risk minimization plans should be prepared.
These plans may include policies and procedures to ensure the identified risks are
prevented and/or minimized to an acceptable level. These risk minimization
activities are classified into (a) routine risk minimization and (b) additional risk
minimization.
Routine risk minimization activities are those planned activities conducted by the
drug establishment regularly to minimize risks. Additional risk minimization
activities are those planned activities conducted by the drug establishment when
routine risk minimization activities are not sufficient to manage a risk, or should a
significant risk occur.
For identified risks with no recommended minimization activities, appropriate
justification must be provided.
4.1.4 Risk Communication
The drug establishment should establish a communication system to ensure that
identified risks that warrant appropriate communication (1) internally, (2) to FDA,
(3) to healthcare professionals and consumers, and/or (4) other stakeholders such
as the Department of Health (DOH) and the Local Government Unit (LGU) are
properly communicated. The system must clearly specify the situations/criteria
wherein risk communication must be done, as weU as the means for
communicating.
In addition, the drug establishment should also describe its internal reporting
procedures to ensure that all important risks are communicated to its management
and the FDA.
4.1.5 Risk Monitoring and Management Evaluation
Risk management systems should be reviewed periodically. Policies and
procedures to that effect should be in place, specifying the frequency of
evaluation.
Page 3 of 4
. \
In addition, once a risk occurred, the RMP should also be reviewed. Review of the
implementation of the different planned activities must be done.
For situations warranting revision of the RMP, these must also be described.
The format described above is attached as Annex A. Existing RMPs of licensed
establishments are acceptable so long as they are equivalent with those described
above. Sample RMP for drug distributors and retailers are attached as Annex B and C,
respectively.
[Link];ew ofRMP
The RMP must always be available for inspection at any time the drug
establishment is open for business. RMP shall be reviewed by FDA in the event that a
trigger (i.e., situations wherein the quality, safety and efficacy of a product has been
compromised) has occurred.
Upfront submission is not required, except for manufacturers wherein the
RMP is part of the Site Master File (SMF).
5. REPEALING CLAUSE/SEPARABILITYCLAUSE
Provisions in previous circulars and memoranda that are inconsistent with this
Circular are hereby withdrawn, repealed, and/or revoked accordingly.
If any provision in this FDA Circular, or application of such provision to any
circumstances, is held invalid, the remainder of the provisions in this FDA Circular
shall not be affected.
6. EFFECTIVITY
This Circular shall take effect immediately
120151007114127
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Page 4 of 4
Annex A
Risk ManagementPlan Format
Sec.A Introduction
1. Internal Environment
2. Risk Management Approach
3. Risk Management Objectives
4. Data Lock Point
Sec.B Risk Identification
1. Risk Universe
2. Risk Assessment
3. Summary Risk Register
4. Unknown Risks
Sec. C Risk Minimization
l. Routine Risk Minimization
2. Additional Risk Minimization
3. Justification for Identified Risks without Minimization Activities
Sec. D Risk Communication
1. Intema] Communication
2. Communication to FDA
3. Communication to Consumers and Healthcare Professionals
4. Communication to Other Stakeholders
Sec.E Risk Monitoring and Management Evaluation
1. Routine Evaluation
2. Additional Eva]uation
AnnexB
Sample Risk Management Plan for Drug Distributors
Sec. A: Introduction
l. Internal Environment
ABC Pharma Inc., is a licensed drug distributor-importer with license number L T0-
123456 located at Alabang, MuntinJupa city.
ABC Pharma Inc. is owned by Juan dela Cruz.
ABC Pharma Inc., is Licensed to import raw materials, active ingredients and/or finished
products for wholesale distribution to other local FDA-licensed drug establishments.
The following are my responsibilities as an importer:
• My establishment is open for business hours only under the supervision of my
PRC registered pharmacist
• The approved and valid License to Operate is displayed in a conspicuous place of
the establishment
• Comply with regulatory standards of FDA, in particular good distribution and
storage practices
• Ensure that I conduct business with legal entities/licensed establishments
• Ensure the products we distribute and/or sell are registered or to be registered
with FDA prior to distribution or saJe;
As a Marketing Authorization Holder, the following are my responsibilities with regard
to my prcducts:
• Ensure that current Good Manufacturing Practice Guidelines is applied in fuJI in
the manufacture of my products
• Ensure that the formulation per dosage form is in agreement with the master
formula and with the batch manufacturing record forms
• Ensure that the manufacturing procedure is. exactly as specified in the master
formula and batch manufacturing records
• Ensure that each batch of all finished and starting materials is tested or certified
against the full specifications and fully complied with before it is released for
manufacturing/distribution purposes
• Ensure tbat all APis are obtained. from legally authorized and qualified sources
• Assume primary responsibility and/or stewardship over the product in case of
liability, adverse events, and/or other public health & safety issues
Attached is the organizational chart of the establishment, inc1uding the Risk Management
Team.
In case of emergency, the following are the contact information of the members of the
Risk Management Team
- A
- B
- c
2. Risk Management Approach
As a general rule, the team meets every 3rd week of the last month of the quarter to
conduct its periodic review of risk management. Minutes and attendance are taken. The
SOP (SOP #1234) for the risk management review is attached.
3. Risk Management Objectives
Our general risk management objective i.s to ensure the safety, efficacy, and quality of
drug products, and [Link] compliance with regulatory requirements Specifically:
• Ensure compliance to regulatory action
• Ensure compliance to GSP
• Ensure compliance to ethical business practices
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Objective name Particulars KRA KPI
Compfiance to Comp[iance to Furr compliance; Up to date list of
regulatory action product recalls immediate removal advisories; complete
from retailers documentation on
recalls
Comp] iance to Compliance to Products stored Consistent
GSP Cold-chain and maintained in terrrperamre on
correct temn monitoring charts
Cmpliance to Ensure Good performance Less than 2
ethical business compliance to of detailmen complaints/ reports
practices MCPs received
4. Data Lock Point
With the recently promulgation of the MCPs, our data lock point is six months.
Within 2 months of the end of the data lock point, we commit to revise the RMP
Sec. B: Risk Identification
1. Risk Uni verse
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RecalJ Submission of CAPA Renortina to Iosoector
Lack C1f time to check
Poor internet connection
Clients demanding for
product
Difficulty in coordinating
with retailers
Poor distribution records
(for example, highest risk)
-OSP.
Cold-chain
Promotion Advertisinz Conventions
No time to review
promotional materials
Misleading promotional
desizns
Low technical skills of
and/or unethical detailmen
(for example, highest risk)
Pressure from physicians
Pressure from global
2. Risk Assessment
Delphi method was used to assess the risks identified in the risk universe and prioritize
them.
3. Summary Risk Register
Distribution Records Risk Incomplete/poorly Compliance to regulatory
managed records will action
hamper the process of
recall
Power-outage Risk Power-outage will result Compliance to GSP
into fluctuation in the
temperature within the
warehouse, and the
shutting-down of cold
rooms/walk-in freezers
Detailmen Promotion Risk Low technical skills of compliance to ethical
and/or unethical detailmen business practices
- poor training will result to
low technical skills and/or
unethical detailmen
4. Unknown Risks
The risk management team, as part of the periodic review, will also address risks not
....
previously identified following SOP 5678.
Sec. C: Risk Minimization
Distribution Records Risk Ensure all relevant Special project to complete
rs
infarmatiorr corrrplete irr existing records/probtematic
the records records
Power-outage Risk ReguJarly view power Additional back-up generator
interru tion schedule
Regular maintenance of Warning/ sanction+ re-training/
Detailmen Promotion Risk enerasor
i--~~~~~~~~--1
orientation following SOP
Re-trainin 1214515
Sec. D: Risk Communication
Distribution .Reeordl Risk
Criteria Communication Content Medium
Recall from FDA Inform records management Phone
team to review distribution
records immediately
Voluntary Recall Inform records management Phone
team to review distribution
records immediately
Power-: · .· Risk .· .,
Criteria Communication Content Medium
Continued power- Provide information to Phone
outage management/maintenance regarding the
risks to quality and their preparation
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,- Trainiu'Risk ·-
Criteria Communication Content Medium
Reporting of Physician of Memo as warning the Format Letter
unethical/misleading detail men of the complaint
promotional practices received
Monitoring of BOP-PRC Memo as warning the Formal Letter
detailmen of the complaint
received
Monitoring of FDA Memo as warning the F onnal Letter
detailmen of the complaint
received
Sec. E: Risk Monitoring and Management Evaluation
The RMP will be reviewed and revised at the end of the data lock point. Review shall follow
SOP 124345
RMP shall be reviewed in instances the identified risks occur which needed additional risk
management.
Annexe
Sample Risk Management Plan for Drugstores
Sec. A: lntroduction
1. Internal Environment
DEF Drugs is a I icensed drugstore with I icense number LTO- 123456 located at Alabang,
Muntinlupa city.
DEF Drugs is owned by Juan dela Cruz.
DEF Drugs is licensed to sell registered drug products, including temperature sensitive
products, specificaJly vaccines to the general public on a retail basis.
The following are my responsibilities as an drugstore (petition form):
• My establishment is open for business hours only under the supervision of my
PRC registered pharmacist
• The approved and valid License to Operate is displayed in a conspicuous place of
the establishment
• Comply with regulatory standards of FDA, in particular good distribution and
storage practices
• Ensure that I conduct business with legal entities/licensed establishments
• Ensure the products we distribute and/or seJl are registered or to be registered
with FDA prior to sale;
Attached is the organizational chart of the establishment.
In case of emergency, the following are the contact information of the members of the
Risk Management Officer
- A
- B
- c
2. Risk Management Approach
The risk management officer regularly meets the team and facilitates the meeting every
1st week of June to conduct its periodic review of risk management. Minutes and
attendaaee are taken. The SOP (SOP # 1234) for the Fisk management review is- anached.
3. Risk Management Objectives
As a licensed drugstore, our general risk management objective is to ensure the safety,
efficacy, and quality of drug products, and ensure compliance with regulatory
requirements. Specifically:
• Regular updating to advisories and policies
• Ensure compliance to regulatory action
• Ensure compliance to GSP
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Objective name Particulars KRA KPI
Update to Up to date review Full compliance Up to date list of
advisories and ofissued advisories
policies advisories
pertaining to
safety of drug
products
Up to date review FuU compliance Up to date list of
of laws affecting policies and SOPs
drugstores
Compliance to Compliance to Full compliance; Up to date List of
regulatory action product recalls immediate advisories;
removal from shelf documentation on
returns
Compliance to Compliance to Products stored Consistent temperature
GSP Cold-chain and maintained in on monitoring charts
Compliance to correct temp
room temperature
monitoring
4. Data Lock Point
Since most objectives are done routinely, the data lock point is set 2 months before the
expiration of the validity of the LTO.
Sec. B: Risk Identification
1. Risk Universe
Un to Date Advaoria aad PoliclM
FDA Advisories AO. FDA Circulars, Memos,
Memorandum Ctrcnlars
Lackof time to check
Lack of time to meet and discuss
Lack of time to change SOPs
Poor internet connection
Malfunctioning computer
Difficulty in interpreting/for example, highest risk)
action
Recall Submission of CAPA Re
Lack of time to checi:(for
exam le, hi hest risk
Poor internet connection
Clients demandrng for
roduct to be dis ensed
;;,
.
.. GSP
Cold-chain Room-tern peratu re Lock and Key Products
1-1• odncts
Irregularly checking
LackofSOPs
Malfunctioning monitoring equipment
Power-outage(for example, highest risk)
Malfunctioning- refrigerator
2. Risk Assessment
Delphi method was used to assess the risks identified in the risk universe and prioritize
them.
3. Summary Risk Register
Interpretation Risk Low technical skills/poor Up to date advisories and
understanding of the policies
Adviso to com I
Time Management Risk Poor time management of Compliance to regulatory
staff resulting to neglect in action
checking the FDA website
for recalls
Power-outage Risk Power-outage will result Compliance to GSP
into fluctuation in the
temperature within the
store, and the shutting-
down of refri erator
4. [Link] Risks
The risk management officer, in coordination with the store staff, as part of the periodic
review, will also address risks not previously identified following SOP 5678.
Sec. C: Risk Minimization
[Link] Additit,ulRisk
Mtiuinizition
Interpretation Risk Conduct regular discussion Consult with local chapter or
with staff and owner national association
Consult with FDA
Time Management - Risk Allot specific time for No additional risk
checkin FDA Website
~~~~~~~~~~----i
minimization required
Conduct regular discussion
with staff and owner
(presentation of new policies)
and removal from shelf
Power-outage Risk Regularly view power Continued power-outage:
rrrrerru ton schedule transfer roducts
Preparation of contingency
Cooler/ enerator
Sec. D: Risk
_.
Communication
Time u----·meat Risk
Criteria Communication Content Medium
Supplier has not contacted Follow-up supplier Phone
the store on products
recalled
Power Ou
Criteria Communication Content Medium
. .
Continued power- Phone
outage
Contact supplier for any assistance Phone
Sec. E: Risk Monitoring and Management Evaluation
The RMP will be reviewed and revised at the end of the data lock point. Review shall follow
SOP 124345
[Link] shall be reviewed in instances the identified risks occur which needed additional risk
management.
