Siza International (Pvt.

) Ltd
Quality Control Department SOP for Sampling of Raw materials

Document No: QC-GEN-005 Effective Date: 22.12.2020 Version: 02

Superseded by: SIZA/QC/GSOP/005 Revision Date: 22.12.2022 Page 1 of 7

1.0 PURPOSE

1.1 To describe the procedures for sampling of raw materials including both
active pharmaceutical ingredients (API) and excipients.

2.0 SCOPE

2.1 The scope of this SOP pertains to sampling of all raw materials (API and
excipients) in the raw material store of Siza International (Pvt.) Ltd.
3.0 RESPONSIBILITIES

3.1 It is the responsibility of QC Analyst to follow this SOP as it is written.

3.2 It is the responsibility of QC Manager to make certain that this SOP is

followed in its entirety, review and update as necessary.
4.0 DEFINITIONS

4.1 Active Pharmaceutical Ingredient: Any substance or mixture of substances

intended to be used in the manufacture of a drug (medicinal) product and that,
when used in the production of a drug, becomes an active ingredient of the
drug product. Such substances are intended to furnish pharmacological
activity or other direct effect in the diagnosis, cure, mitigation, treatment, or
prevention of disease or to affect the structure and function of the body.

4.2 Inactive Ingredient (Excipient): Inactive ingredient means any component

other than an active ingredient.

4.3 Re-Test: The term re-test means the samples are needed to be repeated
analysis for identification according to previous documentation and it has to
be done every 12 months.

5.0 MATERIALS AND EQUIPMENTS

5.1 Sampling Bags.

5.2 Cutter.
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 Siza International (Pvt.) Ltd
Quality Control Department SOP for Sampling of Raw materials

Document No: QC-GEN-005 Effective Date: 22.12.2020 Version: 02

Superseded by: SIZA/QC/GSOP/005 Revision Date: 22.12.2022 Page 2 of 7

5.3 Zone Sampler

5.4 Sampler.

5.5 Spatula

5.6 Pipette, pipette filler, sampling bottle.

6.0 SAFETY CONSIDERATIONS

6.1 Sampling should be performed in a designated sampling area to prevent cross

contamination in the raw material store.

6.2 Wear proper gloves and safety glasses while sampling.

7.0 PROCEDURES
7.1 After receiving and storing in Quarantine area, Raw material store Supervisor
fills the “RAW MATERIAL SAMPLING INTIMATION”, and forward it to
QC. It contains the following information:

7.1.1 Material Name

7.1.2 No. of Packs

7.1.3 Batch Number

7.1.4 Manufacturer

7.1.5 Manufacturing Date

7.1.6 Expiry Date

7.1.7 Quantity received

7.1.8 Receiving Date

7.1.9 GRN Number

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 Siza International (Pvt.) Ltd
Quality Control Department SOP for Sampling of Raw materials

Document No: QC-GEN-005 Effective Date: 22.12.2020 Version: 02

Superseded by: SIZA/QC/GSOP/005 Revision Date: 22.12.2022 Page 3 of 7

7.2 QC Analyst receives the request and records the following information in the
raw material receiving register.

7.2.1 Test Performed By

7.2.2 Result conforms to specifications
7.2.3 QC Number
7.2.4 Remarks (After completion of analysis, Released or Rejected)
7.2.5 Date (of analysis)

7.3 The QC number consists of “RYM0000”,

Where
R represents Raw material
Y represents year.
M represents month
0000 represents sequential number starting from 001 to 9999.

Example: R1801001.

7.4 Sequential number restarts from 0001 at beginning of every year.

7.5 Containers of raw material should be de-dusted prior to transfer to sampling area
by store staff.

7.6 Sample only cleaned, properly labeled and undamaged containers under the dust
collecting hood.

7.7 Containers of raw materials are opened by QC Analyst according to the following
scheme:

7.7.1 Card board cartons: Unfold the top side and cut the container seal.

7.7.2 Plastic and cardboard drums: Cut the outer seal and remove the lid.

7.7.3 Iron drums: Open the lid

7.7.4 Sealed bags and sealed sacks: Do not open, Use Puncture

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 Siza International (Pvt.) Ltd
Quality Control Department SOP for Sampling of Raw materials

Document No: QC-GEN-005 Effective Date: 22.12.2020 Version: 02

Superseded by: SIZA/QC/GSOP/005 Revision Date: 22.12.2022 Page 4 of 7

7.8 Sampling plan

7.8.1 All sampling regardless of the nature of materials are performed by the
QC Analyst.

7.8.2 In case of Active materials all containers are to be sampled.

7.8.3 In case of in-active materials, the number of containers to be sampled

is determined by the formula √N + 1, where N is the number of
containers received.

7.8.4 Minimum criteria for sampling of in-active raw materials

7.8.5 If Number of containers more than 4 then apply the formula √N + 1,

where N is the number of containers received.
7.8.6 If number of containers less than 4, then all containers are to be
sampled for in-active raw materials

7.9 Sampling of Liquid Materials

7.9.1 Open the lid of the container by using appropriate tools. Take
approximately 50 – 60 ml liquid sample with the help of a pipette if
container is of small size

7.9.2 Take approximately 100 ml of sample with the help of solvent pump,
if liquid material is in drum or in large container.

7.9.3 Pour liquid sample in the sampling bottle.

7.10 Sampling of Solid Materials

7.10.1 Usage of zone sampler

7.10.2 Container height MORE THAN 250mm use the Zone sampler for
sampling

7.10.3 Use the cleaned stainless steel spoon or Zone sampler to draw sample
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 Siza International (Pvt.) Ltd
Quality Control Department SOP for Sampling of Raw materials

Document No: QC-GEN-005 Effective Date: 22.12.2020 Version: 02

Superseded by: SIZA/QC/GSOP/005 Revision Date: 22.12.2022 Page 5 of 7

7.10.4 Remove the material from the container with the help of spoon or
Zone sampler

7.10.5 Amount of sample drawn from each container is usually between 5 to

10 gm for APIs and 10 – 15 gm for Inactive materials.

7.10.6 Transfer the sample in properly labeled polyethylene bags.

7.11 After sampling label all raw material containers with the “SAMPLED” label
(Off-white color label with the word “SAMPLED” in dark blue color in the
centre).

7.12 The sample bag is labeled at least with the following information:

7.12.1 Raw Material Name

7.12.2 QC No.

7.12.3 Signature (initials) of QC Analyst

7.12.4 Container No.

7.13 Upon completion of sampling QC Analyst brings samples to lab.

7.14 QC performs testing according to approved testing procedures.

7.15 QC records the testing result in the “Raw Material Templates”

7.16 QC issues a raw material “Certificate of Analysis” on the basis of the results.

7.17 Raw material store Supervisor is intimated with the testing results through a
“RELEASED” label issued by QC which contains the following information:

7.17.1 Product / Item Name

7.17.2 Batch No.

7.17.3 Mfg. Date.

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 Siza International (Pvt.) Ltd
Quality Control Department SOP for Sampling of Raw materials

Document No: QC-GEN-005 Effective Date: 22.12.2020 Version: 02

Superseded by: SIZA/QC/GSOP/005 Revision Date: 22.12.2022 Page 6 of 7

7.17.4 Exp. Date

7.17.5 Quantity

7.17.6 Date of analysis

7.17.7 Due date of analysis

7.17.8 Assay (as such)

7.17.9 Assay ( on dried basis)

7.17.10 Q. C. No.

7.17.11 Pack Size

7.17.12 Remarks

7.17.13 Analyst

7.17.14 QC Manager

7.18 On receiving the QC Released Label, the released raw materials are
transferred to specified release area of raw material store.

7.19 The material which does not conform to the specifications is labeled as
“REJECTED” and is transferred to Reject Material section of store.

7.20 For Retest Analysis, Raw Materials are retested against their
specifications and it has to be done every 12 months.

8.0 DOCUMENT REQUIRED

NA

9.0 REFERENCE DOCUMENT

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 Siza International (Pvt.) Ltd
Quality Control Department SOP for Sampling of Raw materials

Document No: QC-GEN-005 Effective Date: 22.12.2020 Version: 02

Superseded by: SIZA/QC/GSOP/005 Revision Date: 22.12.2022 Page 7 of 7

NA

10 List of Recipients

Issued on withdrawn on
Recipients
(Date / Signature) (Date / Signature)
Quality Control
QC Analyst

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