INTRINSIC RISK CRITERIA/SCORING FOR DRUG MANUFACTURER

Name of Established : ABCDE LABORATORIES, INC. LTO No.: LTO-3000001234567

Site Address : XYZ Industrial Park, Broadyway St., Manila

COMPLEXITY
SITE COMPLEXITY LOW = 1 MEDIUM =2 HIGH = 3 Score
1 Size 200 sqm and below 201 sqm to 500sqm 501sqm and above
2 No. of years of existence 1-5 years 6-10 years 11 years and above
3 Product line (liquid, solid, semi-solid & sterile, non- 1-3 line 4-6 lines 7 and above lines
sterile)
4 Dedication of equipment/campaign dedicated dedicated and campaign
campaign
5 No.of staff below 50 51-200 201 and above
6 Manufacture of own products/ no.of client manufacturer of own manufacturer of own manufacturer of own
product product and/or 1 to 3 product and/or 4 and
drug traders above drug traders
PROCESS COMPLEXITY
7 Product category HR,Medical Gas, Terminal sterilization Aseptic sterilization,
Non-sterile, TMHS,
Repacker
8 Parametric release without with
9 Critical steps involved - special environmental without Special with special
conditions (i.e heat sensitive, RH, light sensitive) requirements requirements
10 Potency non-potent modified-release potent
11 processing stages (i.e compounding, filling, packing) one stage process two to three four processes and
processes above
12 packer/repacker - primary and secondary includes primary and primary for non- primary packaging
secondary packaging sterile products for bulk sterile
product

13 biological processes without biological with biological

process process
PRODUCT COMPLEXITY
No.of components/pack - multiple active ingredients one two to three 4 and above
Special storage (ie radiopharma/ cold chain) room temp cool temp 8-15 C/ cold temp/ light
with RH requirement sensitive/ radioactive
barrier containment/
cryogenic storage
COMPLEXITY TOTAL 0
CRITICALITY
PRODUCT CRITICALITY LOW = 1 MEDIUM =2 HIGH = 3
1 essential product/ therapeutic category HR, TMHS, OTC Complementary List, Core list/ Anti
drugs, supplements/ dermatological Cancer, TB drugs,
vitamins products, others Antibiotics, Vaccine
& Biologicals, Blood
& Blood products,
Emergency Drugs,

2 availability of the product 21 and above 6 to 20 1-5

manufacturer manufacturers source/manufacturer

CRITICALITY TOTAL 0

COMPLEXITY SCORE = SUM TOTAL DIVIDE BY 15 0

*round off to the nearest whole number

CRITICALITY SCORE = SUM TOTAL DIVIDE BY 2 0

*round off to the nearest whole number

Prepared by:
Date: