SAMPLING PLAN

- A sampling plan is a definite working rule regarding size and frequency of sample and the basis for
acceptance or rejection
- Sampling plans can be designed and applied in such a manner as to reduce these risks to a minimum
and over a period of time, give assurance of quality products
- In sampling, one must consider the laws of probability.
- Risks of error:
o Producer’s risk ( ∞ ) is the probability of rejecting a good batch
o Consumer’s risk ( β ) is the probability of accepting a bad batch.

- It requires that three numbers be specified:

o number of items (N) in the lot or batch from which the ample is drawn
o number of items (n) in the random sample drawn from the lot
o acceptance number (c).
o Example, if N = 50, n = 5, c = 0; these three numbers may be interpreted as saying: “Take
a random sample of 5 from a lot of 50. If the sample contains more than 0 defects, reject
the lot; otherwise, accept the lot.”

- There are several sampling plans on hand. One simple sampling plan is the square root system
which uses the formula: n = √N + 1.
- The acceptance number is specified by the AQL (acceptable quality level).

- Another sampling plan which has found wide acceptance throughout the industrial world is the
government sampling plan.
- It consists of master tables first developed in 1942 by a group of engineers from the Bell Telephone
Laboratories.
- These tables were further developed and adopted by the US Department of Defense. Thus, they
are now known as the military standards.
- An international designation of the MILD-STD-105D is the ABC-STD-105D derived from the ABC
Working Group, a committee from the military agencies of the United States of America, Great
Britain, and Canada. This table is used for sampling by attributes,
- Acceptance sampling by variables make use of MIL-STD-414.
MATERIAL CONTROL

 As each batch of incoming material is received, it is given a receiving number by which it will be
identified in subsequent operation. A receiving number should have distinguishing characteristics,
which will prevent possible confusion with any number previously placed on the container by the
supplier.

 A receiving tally report (reception of materials, incoming cargo report, receiving report or receiving
ticket) should be prepared for every shipment. Information indicated therein are as follows: (refer to
sample form below)
I. Pre-printed data
1. Name of report
2. Name of drug/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/distributor)
7. Unit of measure
8. Number of containers received
9. Weight/volume/pieces contained in each container
10. Date the report was prepared
11. Date the shipment was received
12. Name of warehouse personnel receiving the shipment
B. Quality Control
1. Inspector’s report
a. Quantity of sample c. Name of inspector
b. Comments, if any d. Date inspected
2. Analysis
a. Analytical reference number c. Date of analysis
b. Name of analyst
3. Disposition
a. Reason if rejected
b. If approved
b-1) Reassay date
b-2) Release number
4. Name of the person responsible for receiving the report
5. Date of the review
  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. Thus a copy of the RTR is given to quality control,
warehouse, purchasing, and accounting departments.
 Manufacturing firms may have different entries but the basic information is quite similar.
 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 MATERIALS
 Raw materials are the ingredients intended for use in the manufacture of drugs and cosmetics,
including those that may not appear in the final product.
 The control of raw materials at different stages 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 transit, including
breakage of seals when indicated.
3. Adequate number of samples are taken from a representative number of containers.
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 for a complete test 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 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 the FIFO (first in, first out) policy.

STICKERS

 In order to avoid mix-ups, a material warehouse is subdivided into several sections. Accordingly, the
materials are segregated and properly identified by the stickers attached on the individual containers,
cage or pallet of materials.
 On reception of the materials, a quarantine sticker is pasted on the container of the material. 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 defaced or removed prior to attaching the approved or
rejected sticker. Under no circumstances should two different stickers 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 for 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.
------------------------------------------
RTR No. _________

RECEIVING TALLY REPORT

DR No.__________ PO No ______ Date Received___________

Supplier ____________________________________
Quantity Unit Description Quantity/Container

Received above items in good order and condition

By _____________________________ Date ________________

No. of containers sampled _____________ Quantity of sample_____

Comments

Sampled and inspected by ________________ Date _________________

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Analytical Report No.__________

Sample [ ] meets specifications

[ ] does not meet specifications
Reason ___________________________________________________________
__________________________________________________________________

Tested by _________________ Date _____________

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DISPOSITION
[ ] I Approved Retest date
[ ] Rejected

Reviewed by _________________________ Date _____________

QC Manager