2.

4 Quality Risk Management (QRM)

Quality risk management is a systematic process for the assessment, control,
communication and review of risks to the quality of the drug product across the product
lifecycle. The evaluation of the risk to quality is be based on scientific knowledge and
ultimately link to the protection of the patient and the level of effort, formality, and
documentation of the quality risk management process is commensurate with the level
of risk.
- Basic risk management facilitation methods (flowcharts, check sheets, process
mapping and cause and effect diagrams)
- Failure Mode Effects Analysis (FMEA) which identifies potential failures and
quote them in order to rank them
- Fault Tree Analysis (FTA) that identifies causes of an undesired event
- Hazard Analysis and Critical Control Points (HACCP) which appreciates and
control risk contamination
- Preliminary Hazard Analysis (PHA) that identifies potentially hazardous events
- Risk ranking and filtering which ranks items following on criticality level
The scope of QRM include development, manufacturing, distribution, inspection, and
submission/review processes throughout the lifecycle of drug substances, drug
products, biological and biotechnological products (including the use of raw materials,
solvents, excipients, packaging and labeling materials in drug products/facilities,
biological and biotechnological products).

2.5 Product Quality Reviews

Drugnosis Inc., will identify all quality attributes based on process and product
understanding. Use QRM to identify critical quality attributes. Establish the control
strategy and continuously look for spaces of improvements. There will be regular
periodic quality reviews of all products with the objective of verifying the consistency of
the existing process, the appropriateness of current specifications for both starting
materials and finished products, to highlight any trends and to identify product and
process improvements.
Reviews are limited to:
- Starting materials including packaging materials used in the product
- Critical in-process controls and finished products results
- All batches that failed to meet established specifications and their investigation
- All significant deviations
- Changes carried out to the process
- Results of the monitoring program and any adverse trends
- Quality related returns
Follow-up actions may be included:
- Product process, formulation and analytical method improvements
- In-process or final product specification review
- Revalidation
- Product recall or withdrawal
3. Personnel

Althea V. Gales
Chairman

Darlene A. Blaya Vice-

Chairman

Patricia J. Molina Human

Resource Director

Alliah J. Gonzaga
Angelique L. Mondragon
Marketing Director Research and Development
Director

Khairea H. Jabarani Shanelle L. Tan Quality Kathleen B. Canono

Sales Manager Control Manager Production Manager

There are 50 employees engaged in quality management under the supervision of Ms.
Molina, 95 employees under Ms. Canono for production, 25 employees under Ms. Tan
for quality control and 90 employees under Ms. Mondragon and Ms. Jabarani in storage
and distribution of products. Under the supervision of the chairman, vice-chairman, and
the HR director, there are 45 employees in-charge of the reviews, processing of
documents and other file-related services/operations.