MATERIAL

CONTROL

Raw materials
Printed materials
Packaging materials

Prepared by:
RacquelALLPPT.com
Aurea_ Free
C. PowerPoint
Balangue, Templates, RPh, MSPh
Diagrams and Charts
Separate
Receiving
receiving
number
number should
should
be
be assignedfrom
different for
the
eachsupplier
lot
RECEIVING TALLY REPORT (RTR)
 Reception of materials, incoming cargo report, receiving report, receiving ticket
 document the contents of a delivery to a business
 Should be prepared for every shipment
 Should be distributed to all departments/groups concerned with purchase,
inventory, use and control of materials
o Warehouse
o Quality control
o Purchasing
o Accounting
 Physical and organoleptic tests
RAW MATERIALS
Identification tests
Limits of impurities and degradation
Potency or Assay
Microbial tests

Ingredients intended for use

in the manufacture of drugs and
cosmetics, including those that may
not appear in the final product
RAW MATERIAL SPECIFICATIONS

Description Solubility Identity

Purity and Quality Assay Microbial limits

 Appearance

RE-TEST / RE-ASSAY Identification

Melting range

Requirements for Re-Test

Specific gravity
Re-Assay
Dates Refractive index
Month/year
pH, Acidity, Alkalinity
Highly Vitamins, Active Active
unstable ingredients, ingredients, Loss on drying, Moisture/Water con-
materials flavorants Dyes tent
excipients
monthly or 6 months 12 months 24 months
prior to use
Alcohol content

Degradation limits

Assay

Microbial test
STICKERS
PRINTED AND PACKAGING MATERIALS
Primary packaging components Secondary packaging components

Printed Materials
CONTAINERS
Check for
Check for
tightness
leaks
of caps
CONTROL OF CONTAINERS
Physical Inspections

1. Shape 12. Peeling

2. Volume 13. Cleanliness
3. Finish 14. Light transmission
4. Opening 15. Stress crack resistance
5. Diameter 16. Torque – measure of circular force required to
6. Height loosen the cap
7. Thickness
8. Color
9. Clarity
10. Leak
11. Print
CONTROL OF CONTAINERS
Physico-chemical tests

1. Identification
2. Infra-red properties – for polyethylene containers
3. Thermal analysis – for glass containers
4. Extractable substance – for plastics
5. Non-volatile residue – for plastics
6. Water vapor permeation/transmission – for polyethylene containers
7. Moisture
8. Resistance to crack
LABELING CONTROL
A. LABELS
1. Name of drug or cosmetic
2. Strength or quantity of the substance contained per dosage form
3. Lot or batch number
4. Expiration date
5. Registration number
6. Storage condition
7. Name of manufacturer, packer or distributor
8. Business address
9. Quantity of contents of package
10. Names and quantities of components in the preparation
11. Rx symbol (if necessary)
12. Warning or precaution
13. Adequate direction for use
LABELING CONTROL
B. PACKAGE INSERT
1. Product Name
2. Strength or quantity of the active substance contained per dosage form
3. Description
4. Action
5. Indication
6. Contraindication
7. Warnings
8. Precautions
9. Adverse reactions
10. Dosage and administration
11. Overdosage
12. How supplied
13. Manufacturer/packer/distributor
14. Business address
 References
Drug and Cosmetic Quality Control with Instrumentation
by: N. Lerma and M. Osi

Remington: The Science and Practice of Pharmacy

United States Pharmacopeia-National Formulary (USP-NF)

https://ww2.fda.gov.ph/index.php/issuances-2/pharml-1/pharml-administrative-order