UNIT III.

Material Control

OBJECTIVES:
At the end of the session, the students should be able to:
1. Discuss how they materials are being checked and labeled.
2. Enumerate the information needed to be seen in different materials.
3. Identify the tests used for materials being distributed.

LECTURE NOTES:
MATERIAL CONTROL
A receiving tally report (reception of materials, incoming cargo report, receiving report or receiving ticket.
Information) indicated therein as follows
I. Pre-printed data
1. Name of report
2. Name of the drug or cosmetic company
3. Address
4. Receiving number
5. Name of the department receiving a copy

II. Information to be supplied by:

A. Warehouse
1. Name of the material
2. Item code number
3. Label claim
4. Purchase order number
5. Invoice number
6. Vendor (supplier or distributor)
7. Unit of measure
8. Number of containers received
9. Weight or volume or pieces contained in each container
10. Date the report was prepared
11. Date the shipment was receive
12. Name of warehouse personnel receiving the shipment.

B. Quality Control
1. Inspector's report
A. Quantity of sample
b. Comments, if any
c. Name of inspector
d. Date inspected
2. Analysis
a. Analytical reference number
b. Name of analyst
c. Date of analysis

3. Disposition
a. Reason if rejected
b. If approved
b-1) Reassay date
 b-2) Release number 5. Date of the review
4. Name of the person responsible for receiving the
report

If the shipment consists of more than one manufacturing

lot number, a separate receiving number is assigned to each lot.
The receiving tally report (RTR) should be distributed to all
groups concerned with the purchase, inventory, use and control of
the materials. The RTR is prepared in the warehouse by the
warehouse personnel who is responsible for assigning a receiving
number to the material. The shipment is held in quarantine pending
quality control approval.

RAW MATERIAL
Raw materials are the ingredients intended for use in the
manufacture of drugs and cosmetics. The control of raw materials at
different stage is handled in the following manner:

Reception
1. The receiving tally report is checked by a QC inspector for
accuracy.
2. Each container of raw materials is examined visually for
damage or contamination in transmit including breakage of seals
when indicated.
3. Adequate number of samples are taken from a representative
number of containers.
a. A sampling plan is used to determine the number of
raw material container to be sampled.
b. Calculate for the total quantity of material required to determine the amount of sample to be taken from each
container.
c. The composite sample should not be less than three times the amount required for one complete test.

Quarantine
1. The inspector checks that the raw material container has a "Hold" or a quarantine sticker pasted by the receiving
warehouse personnel to indicate that a decision to accept or reject is yet to be made by quality control.
2. Samples are submitted to the laboratory for testing.
3. The sample is subjected to tests such as:
a. Physical and organoleptic examination
b. Identification Tests
c. Limits of impurities and degradation products
d. Potency or assay
e. Microbiological tests
4. If the test results indicate that the raw material meets monograph specifications, the material is approved for use;
otherwise, it is rejected. Decision stickers are then issued by quality control.
5. The decision stickers are either placed on top of the quarantine sticker or the quarantine sticker is first removed before
the decision sticker is pasted. No two stickers of different dispositions must be present on the same container. At this
stage, the raw material is transferred to either the rejected or approved materials area.

Rejected
The material so marked is checked that it is held at a rejected materials area to prevent the possibility of use in
any manufacturing or processing procedure.

Approved
1. The material marked as approved is checked that it is brought to the approved materials area.
2. Approved materials are tested when reassay is date is due to assure that they conform to appropriate specifications of
identity, strength and purity at time of use.
3. Approved raw materials are audited to assure that they are rotated in such a manner that the oldest stock is used
first. This is known as FIFO (first in, first out) policy.

STICKERS

The materials are held in a quarantine area while waiting

for its release by quality control. After disposition is given, the
appropriate sticker is pasted on top of the quarantine sticker; or if it
is more convenient, the quarantine sticker is deface or removed
prior to attaching the approved or rejected sticker. Under no
circumstances should two different stickers should be present or
prominently displayed on a material container at the same time.
To distinguish the sticker, different color codes may be
assigned such as yellow quarantine, green for approved and red
for rejected. A sticker may have any other color but it would be
wise to use a color easily associated with what it means.

PRINTED AND PACKAGING MATERIALS

Product containers, closures and other component parts of
a product package should not be reactive, additive, or absorptive so
as to alter the safety, identity, strength, quality, and purity of the
product. These should be tested for suitability for its intended use. Storage and handling are suited to prevent them from
contamination and to avoid mixups.

Packaging materials are two types, namely:

1. Primary packaging components - packaging materials which come in direct contact with the product itself; like bottles,
tubes, ampuls, vials, carpules, caps, stoppers, plungers, stripping materials, jars, fillers, and seals.
2. Secondary packaging components - packaging materials which do not come in direct contact with the product and
serve as accessory to the primary packaging component. Most of these are labels, inserts, unit cartoons, brochures and
shippers.

Printed Materials
By official definition, labeling includes all written, printed or graphic materials accompanying a product. As such,
they are subject to inspections by an experience proofreader for graphical errors, for compliance with specifications as to
type and grade of stock printing quality and dimensional tolerance.

Minimum criteria for acceptance of printed materials consist of:

1. Test 6. Selability
 2. Color 7. Cleanliness
3. Size 8. Surface finish
4. Thickness 9. Adequate paste
5. Grain direction 10. Shape

LABELING CONTROL
Below is a summary of labeling requirements for drug and cosmetics.
Labels
v1. Name of drug or cosmetic
2. The strength or quantity of the substance contained
per unit 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 if 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

Package Insert
1. Product name 8. Precautions
2. Strength or quantity of the active substance contained 9.Adverse reactions
per unit dosage form 10. Dosage and administration
3. Description 11. Overdosage
4. Action 12. How supplied
5. Indication 13. Manufacturer or packer or distributor
6. Contradictions 14. Business Address
7. Warnings

CONTAINERS
Physical and chemical evaluation of containers like those made of glass, plastic, and metal have been extensive.
Physical inspections generally include the following criteria:

1. Shape 7. Weight
2. Volume 8. Thickness
3. Finish 9. Color
4. Opening 10. Clarity
5. Diameter 11. Leak
6. Height 12. Torque
13 Print 16. Light transmission
14. Feeling of Paint 17. Stress crack resistance
15. Cleanliness

The physico-chemical tests for containers include:

1. Identification 5. Non-volatile residue
2. Infra-red properties 6. Water vapor permeation or transmission
3. Thermal analysis 7. Moisture
4. Extractable substance 8. Resistance to water attack

It should be noted that plastic containers for parenteral use is tested further using biological test procedures: e.g.
implantation, systemic and intracutaneous injections.

Container and Closure Control

Closures should fit the tread of the container. It should sit on a container without tilting, produce no leaks, should not
rotate continuously, be reasonably tighter and look elegant.

The following considerations are very important in this connection:

1. A minimum tightness is essential to avoid evaporation or leakage of the product.
2. Excessive torque may break the moulded closures.
3. Caps applied too tightly may be difficult to remove.

Experience has proven the desirability of regular testing of packages from each bottling line to make sure that the
tightness is maintained at all times. To check tightness, a torque tester is used. Torque is a measure of circular force
required to loosen the cap; an application torque is the amount of force used to tighten the cap. The unit of force is in
terms of inch pound. Sample size is 10 bottles.

REASSAY DATES
Periodic testing is done to revalidate the material. The date of retest is known as reassay date. This is also given in terms
of month and year, determine from the last reassay date.
 Based on the stability of the raw materials, the reassay dates assigned are:
Monthly or prior to use - highly unstable materials
6 months - vitamins, flavors
12 months - active ingredients, dyes
24 months - active ingredients, excipients

Not all tests are performed during a retest. The test given below can only serve as a general guide since
manufacturing companies provide a listing of tests which must be performed to satisfy the reassay requirements for the
raw materials.

Retest requirements:
1. Appearance 8. Alkalinity
2. Identification 9. Acidity
3. Melting range 10. Alcohol content
4. Specific Gravity 11. Degradation limits
5. Refractive index 12. Assay
6. pH 13. Microbial tests
7. Loss on drying, moisture content or water
 FORMATIVE ASSESSMENT:
1. What is the relevance of material control in manufacturing and distributing drug products?
2. Why is reassay important in drugs?

SUMMATIVE ASSESSMENT:
 Please refer to Google Classroom link

REFERENCES:
1. Knevel, Adelbert and Frank DiGangi editors, Jenkin’s Qualitative Pharmaceutical Chemistry, 7th ed.,
New York, McGraw-Hill, Book Co., 1997
2. The United States Pharmacopeia and National Formulary (USP/NF), 2005