RISK
MANAGEMENT
PLAN OF
HEALTHTEACH
NUTRITIONALS
INC.
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SEC. A
INTRODUCTION
1. INTERNAL ENVIRONMENT
Healthtech Nutritionals Inc., is a licensed supplement-distributor with license number
LTO- _______________ located at Phase 1 Atang Dela Rama CCP Complex
Seascape Village Barangay 76, City of Pasay.
Healthtech Nutritionals Inc., is owned by the five (5) incorporators.
Healthtech Nutritionals 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 our
Production manager.
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 sale;
As a Marketing Authorization Holder, the following are my responsibilities with
regard to my products:
Ensure that current Good Manufacturing Practice Guidelines is applied in full
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 records forms
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 that 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 and safety issues
Attached is the organizational chart of the establishment, including the Risk
Management Team.
In case of emergency, the following are the contact information of the members of the
Risk Management Team
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- Kim Chi Crizaldo (0995-137-3707)
2. RISK MANAGEMENT APPROACH
As a general rule, the team meets every 4 th 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 is to ensure the safety, efficacy, and quality of
drug products, and ensure compliance with regulatory requirements Specifically:
- Ensure compliance to regulatory action
- Ensure compliance to GSP
- Ensure compliance to ethical business practices
Objective Category
Objective Name Particulars KRA KPI
Full compliance; Up to date list of
Compliance to Compliance to immediate advisories; complete
regulatory action product recalls removal from documentation on
retailers recalls
Products stored Consistent
Compliance to Compliance to
and maintained in temperature on
GSP Cold-Chain
correct temp monitoring charts
Compliance to Ensure Good Less than 2
ethical business compliance to Performance of complaints/reports
practices MCPs detailmen 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.
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SEC. B
RISK IDENTIFICATION
1. RISK UNIVERSE
Compliance to Regulatory Action
Reporting to
Recall Submission to CAPA
Inspector
Last time to Check
Poor internet
connection
Clients demanding
for products
Difficulty in
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coordinating with
retailers
Poor distribution
records (for
example, highest
risk)
GSP
Irregular checking
Lack of SOPs
Malfunctioning monitoring equipment
Power-outage (for example, highest risk)
Malfunctioning refrigerator
Business Ethics
Promotion Advertising Conventions
No time to review promotional materials
Misleading promotional designs
Low technical skills of and/or unethical
detailmen (for examples, 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
Naming Convention Priority Risk Risk Management
Objective
Distribution records risk Incompletely/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 Low technical skills of Compliance to ethical
risk and/or unethical detailmen business practices
– poor training will result
to low technical skills
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and/or unethical detailmen
4. UNKNOWN RISK
The risk management team, as part of the periodic review, will also address risks not
previously identified following SOP 1234.
SEC. C
RISK MINIMIZATION
Additional Risk
Priority Risk Routine Risk Minimization
Minimization
Ensure all relevant Special project to complete
Distribution Records Risk information is complete in existing records/problematic
records records.
Regularly view power Additional back-up
Power-outage Risk
interruption schedule generator.
Regular maintenance of
Warning/sanction + re-
generator
Detailmen Promotion Risk training/ orientation
--
following SOP 1214515
Re-Training after 1 year
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SEC. D
RISK COMMUNICATION
Distribution Records Risk
Criteria Communication Content Medium
Inform records management
Recall from FDA team to review distribution Phone
records immediately
Inform records management
Voluntary Recall team to review distribution Phone
records immediately
Power Outage Risk
Criteria Communication Content Medium
Memo as warning the
Continue power- outage detailmen of the complaint Phone
received
Detailmen Training Risk
Criteria Communication Content Medium
Reporting of Physician of Memo as warning the
unethical/misleading detailmen of the complaint Formal Letter
promotional practices received
Memo as warning the
Monitoring of BOP-PRC detailmen of the complaint Formal Letter
received
Monitoring of FDA Memo as warning the Formal Letter
detailmen of the complaint
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received
SEC. E
RISK MONITORING AND MANAGEMENT
EVALUATION
The Risk Management Plan will be reviewed and revised at the end of the data lock point.
Review shall follow SOP 12345
Risk Management Plan shall be reviewed in instances the identified risk occur which needed
additional risk management.
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