SOP FOR SAMPLING
1. Purpose:
1.1. This Sop is written to
describe the procedure for sampling of materials/intermediates/bulk/finished
products.
2. Scope:
2.1. It is applicable to
Quality Assurance Department.
3. Responsibility:
3.1. Quality Assurance Manager
3.2. Quality Assurance Officer
4. Procedure:
4.1. Sampling of Raw Materials
4.1.1. On receipt of raw
material, store In-Charge issue GRN No. and sends request for sampling to
Quality Assurance Department.
4.1.2. QA dept. forwards request
to QC dept. to issue control reference number (QC #) to the material.
4.1.3. After issuance of QC
reference number QA dept. personnel writes under test label and samples the raw
material.
4.1.4. In case of more than one
container all containers are sampled for identification and complete test
samples by the formula under square root
of n+1, where n is the total number of containers.
4.1.5. After sampling, sample is
sent to QC dept. for testing.
4.1.6. The results of the
analysis are followed by the Sop: “SOP for Release or rejection of materials”.
4.2. Sampling of Packing
Materials
4.2.1. On receipt of packing
material, store In-Charge issue GRN No. and sends request for sampling to
Quality Assurance Department.
4.2.2. QA dept. forwards request
to QC dept. to issue control reference number (QC #) to the packing material.
4.2.3. After issuance of QC
reference number QA dept. personnel writes under test label and samples the
packing material.
4.2.4. Sampling is done according
to the formula under square root
of n+1, where n is the total number of containers.
4.2.5. After sampling, sample is
sent to QC dept. for testing.
4.2.6. The results of the
examination are followed by the Sop: “SOP for Release or rejection of
materials”.
4.3. Sampling of water
4.3.1. Sampling will be done by
QA personnel by the following procedure:
4.3.2. Before sampling wash hands
with 70% IPA solution dry the hands and wear gloves.
4.3.3. When collecting the sample
take extreme care to avoid contamination from the environment.
4.3.4. Ensure that sample
entering the bottle is not in contact with the hand.
4.3.5. Collect at least 500 ml
sample in the screwed bottle, label it with full detail indicating
4.3.6. Type of water, location of
sample point, date of sampling and signature of sampler.
4.3.7. Deliver the sample to the
laboratory as quickly as possible along with the request for water analysis
form.
4.3.8. A complete record of water
sampling / testing should be maintained in Q.C lab for reference purpose. The
analysis report bearing results of the water analysis will be handed over to QA
department for further action.
4.4. Sampling of Injectable:
4.4.1.
Sampling of Bulk:
4.4.1.1.
Before
sampling wash hands with water and allow drying the hands, and wear gloves and
mask. When collecting the sample take extreme care to avoid contamination from
the environment.
4.4.1.2.
Ensure
that the liquid sample glass beaker has not been in contact with the hands.
4.4.1.3.
Collect
almost 50 ml of the solution in a glass beaker, label it with full detail
indicating name of product, date of sampling and signature of sampler.
4.4.1.4.
Deliver
the sample to the laboratory as quickly as possible along with the request for
analysis form.
4.4.1.5.
A
complete record of bulk sampling / testing should be maintained in Q.C lab for
reference purpose.
4.4.1.6.
The
analysis report bearing results of the bulk sample will be handed over to QA
department for further action.
4.4.2.
Sampling of Filled Vials/ Ampoules:
4.4.2.1.
Before
sampling wash hands with water and allow drying the hands, and wear gloves and
mask.
4.4.2.2.
Collect
the 10 vials/ ampoules in a poly bag for testing purpose, label it with full
detail indicating name of product, date of sampling and signature of sampler.
4.4.2.3.
Deliver
the sample to the laboratory as quickly as possible along with the request for
analysis form.
4.4.2.4.
A
complete record of filled vials/ ampoules sampling/ testing should be maintained
in Q.C lab for reference purpose.
4.4.2.5.
The
analysis report bearing results of the finished product will be handed over to
QA department for further action.
4.5. Sampling of Creams &
Ointments
4.5.1.
Sampling of Bulk:
4.5.1.1.
Before
sampling wash hands with water and allow drying the hands, and wear gloves and
mask. When collecting the sample take extreme care to avoid contamination from
the environment.
4.5.1.2.
Ensure
that the semisolid mass entering the poly bag or glass beaker has not been in
contact with the hands.
4.5.1.3.
Collect
almost 50 grams sample in the poly bag or glass beaker, label it with full
detail indicating name of product, date of sampling and signature of sampler.
4.5.1.4.
Deliver
the sample to the laboratory as quickly as possible along with the request for
analysis form.
4.5.1.5.
A
complete record of bulk sampling / testing should be maintained in Q.C lab for
reference purpose.
4.5.1.6.
The
analysis report bearing results of the bulk sample will be handed over to QA
department for further action.
4.5.2.
Sampling of Finally Packed Tubes (Finished Product):
4.5.2.1.
Before
sampling wash hands with water and allow drying the hands, and wear gloves and
mask.
4.5.2.2.
Collect
the packs of finished product containing almost 10 tubes for testing purpose.
4.5.2.3.
Deliver
the sample to the laboratory as quickly as possible along with the request for
analysis form.
4.5.2.4.
A
complete record of finally packed tubes sampling / testing should be maintained
in Q.C lab for reference purpose.
4.5.2.5.
The
analysis report bearing results of the finished product will be handed over to
QA department for further action.
4.6. Sampling of Tablets
4.6.1.
Sampling of Granules:
4.6.1.1.
Before
sampling wash hands with water and allow drying the hands, and wear gloves and
mask.
4.6.1.2.
When
collecting the sample take extreme care to avoid contamination from the
environment.
4.6.1.3.
Ensure
that the granular powder entering the poly bag has not been in contact with the
hands.
4.6.1.4.
Collect
almost 50 grams sample in the poly bag, label it with full detail indicating
name of product, date of sampling and signature of sampler.
4.6.1.5.
Deliver
the sample to the laboratory as quickly as possible along with the request for
analysis form.
4.6.1.6.
A
complete record of granules sampling / testing should be maintained in Q.C lab
for reference purpose.
4.6.1.7.
The
analysis report bearing results of the granules will be handed over to QA
department for further action.
4.6.2.
Sampling of Compressed Cores / Tablets:
4.6.2.1.
Before
sampling wash hands with water and allow drying the hands, and wear gloves and
mask.
4.6.2.2.
When
collecting the sample take extreme care to avoid contamination from the
environment.
4.6.2.3.
Ensure
that the Cores / Tablets entering the poly bag have not been in contact with
the hands.
4.6.2.4.
Collect
almost 100 cores / tablets in the poly bag, label it with full detail
indicating name of product, date of sampling and signature of sampler.
4.6.2.5.
Deliver
the sample to the laboratory as quickly as possible along with the request for
analysis form.
4.6.2.6.
A
complete record of cores / tablets sampling / testing should be maintained in
Q.C lab for reference purpose.
4.6.2.7.
The
analysis report bearing results of the compressed cores / tablets will be
handed over to QA department for further action.
4.6.3.
Sampling of Coated Tablets: (For Coated Tablets Only):
4.6.3.1.
Before
sampling wash hands with water and allow drying the hands, and wear gloves and
mask.
4.6.3.2.
When
collecting the sample take extreme care to avoid contamination from the
environment.
4.6.3.3.
Ensure
that the coated tablets entering the poly bag have not been in contact with the
hands.
4.6.3.4.
Collect
almost 100 coated tablets in the poly bag, label it with full detail indicating
name of product, date of sampling and signature of sampler.
4.6.3.5.
Deliver
the sample to the laboratory as quickly as possible along with the request for
analysis form.
4.6.3.6.
A
complete record of coated tablets sampling / testing should be maintained in
Q.C lab for reference purpose.
4.6.3.7.
The
analysis report bearing results of the coated tablets will be handed over to QA
department for further action.
4.6.4.
Sampling of Finished Product:
4.6.4.1.
Before
sampling wash hands with water and allow drying the hands, and wear gloves and
mask.
4.6.4.2.
Collect
the packs of finished product containing equivalent to almost 50 tablets for
testing purpose.
4.6.4.3.
Deliver
the sample to the laboratory as quickly as possible along with the request for
analysis form.
4.6.4.4.
A
complete record of finally packed tablets sampling / testing should be maintained
in Q.C lab for reference purpose.
4.6.4.5.
The
analysis report bearing results of the finished product will be handed over to
QA department for further action.
4.7. Sampling of Capsules
4.7.1.
Sampling of Granules:
4.7.1.1.
Before
sampling wash hands with water and allow drying the hands, and wear gloves and
mask.
4.7.1.2.
When
collecting the sample take extreme care to avoid contamination from the
environment.
4.7.1.3.
Ensure
that the granular powder entering the poly bag has not been in contact with the
hands.
4.7.1.4.
Collect
almost 50 grams sample in the poly bag, label it with full detail indicating
name of product, date of sampling and signature of sampler.
4.7.1.5.
Deliver
the sample to the laboratory as quickly as possible along with the request for
analysis form.
4.7.1.6.
A
complete record of granules sampling / testing should be maintained in Q.C lab
for reference purpose. The analysis report bearing results of the granules
shall be handed over to QA department for further action.
4.7.2.
Sampling of Filled Capsules:
4.7.2.1.
Before
sampling wash hands with water and allow drying the hands, and wear gloves and
mask.
4.7.2.2.
When
collecting the sample take extreme care to avoid contamination from the
environment.
4.7.2.3.
Ensure
that the Capsules entering the poly bag have not been in contact with hands.
4.7.2.4.
Collect
almost 100 capsules in the poly bag, label it with full detail indicating name
of product, date of sampling and signature of sampler.
4.7.2.5.
Deliver
the sample to the laboratory as quickly as possible along with the request for
analysis form.
4.7.2.6.
A
complete record of capsules sampling / testing should be maintained in Q.C lab
for reference purpose.
4.7.2.7.
The
analysis report bearing results of the filled capsules will be handed over to
QA department for further action.
4.7.3.
Sampling of Finished Product:
4.7.3.1.
Before
sampling wash hands with water and allow drying the hands, and wear gloves and
mask.
4.7.3.2.
Collect
the packs of finished product containing equivalent to almost 50 capsules for
testing purpose.
4.7.3.3.
Deliver
the sample to the laboratory as quickly as possible along with the request for
analysis format.
4.7.3.4.
A
complete record of finally packed capsules sampling / testing should be
maintained in Q.C lab for reference purpose.
4.7.3.5.
The
analysis report bearing results of the finished product will be handed over to
QA department for further action.
5. List of Recipients:
5.1. Quality Assurance Manager
5.2. Quality Assurance Officer
