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Pharmaceutical Analysis-2 Lecture Sampling Method

This document discusses sampling methods for pharmaceutical analysis. It begins by defining sampling as removing items from a population to make inferences about the entire population. It notes that sampling requires preparation, including having the proper tools and cleaning procedures. The sampling process involves following a written sampling procedure and plan to ensure representative samples are taken in sufficient quantities. Important steps include supervising sample collection, documenting the process, and properly storing and labeling samples in containers that will not interact with or allow contamination of the material. Samples should be stored according to specified conditions and for as long as necessary for testing purposes or to resolve issues.

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Edrick G. Esparraguerra
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83 views12 pages

Pharmaceutical Analysis-2 Lecture Sampling Method

This document discusses sampling methods for pharmaceutical analysis. It begins by defining sampling as removing items from a population to make inferences about the entire population. It notes that sampling requires preparation, including having the proper tools and cleaning procedures. The sampling process involves following a written sampling procedure and plan to ensure representative samples are taken in sufficient quantities. Important steps include supervising sample collection, documenting the process, and properly storing and labeling samples in containers that will not interact with or allow contamination of the material. Samples should be stored according to specified conditions and for as long as necessary for testing purposes or to resolve issues.

Uploaded by

Edrick G. Esparraguerra
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PPTX, PDF, TXT or read online on Scribd
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Pharmaceutical

Analysis- 2 Lecture
Sampling Method
Prof. Anthony R. Marin, RPh., MSPharm
College of Pharmacy
School of Health Science Professions
INTRODUCTION
 Sample
are the unit that provide the experimental observations, such as tablet sampled for potency and
defects.

Sampling
may be defined as the process of removing appropriate number of item from a population in
order to make interferences to the entire population.

Regulatory authorities (including inspectorates), quality control laboratories .


INTRODUCTION
 Before sampling
- purpose of sampling?
- type of tests intended to be applied to the samples?
- type of products/materials to be sampled?
- are responsibilities of the samplers clear?
SAMPLING
PROCESS
 Sampling process
- Preparation for sampling
- Sampling operation
- Sample storage and retention
PREPARATION FOR
SAMPLING
 Sampling tools should be available to the sampler, e.g. to open containers (knives, hammers,...),
material to re-close the packages (sealing tape), self-adhesive labels to indicate that some of the
contents have been removed, etc...

 Sampling tools should be made of inert materials (e.g. polypropylene or stainless steel; avoid
glass) and kept very clean . After use, thoroughly washed, rinsed with water or suitable solvent,
dried and stored in clean conditions.

 Disposable sampling materials can also be used.


 Washing facilities should be located in, or close to, the sampling area.
 Cleaning procedure should be documented and validated.
 Sterile pharmaceutical products should be sampled under aseptic conditions. I - Preparation for
sampling
ASSIGNMENT
 Submit exapmle of Tools of Sampling ( WHO Guidelines)
SAMPLING
OPERATION
 Written sampling procedure: operations to be performed on a defined material for a specific
purpose, including health/safety aspects .

 Sampling plan : description of the location, number of units and/or quantity of material that should
be collected, and associated acceptance criteria.

 Make sure that representative samples are taken in sufficient quantity. Representative sample:
sample obtained according to a sampling procedure designed to ensure that the different parts of a
batch or the different properties of a non-uniform material are proportionately represented.

 Samples should never be returned to the bulk.


CONT..
 Sampling operations should be supervised and documented => sample collection form => always
kept together with the collected sample.

 Sample collection form : written record of the sampling operations, containing: batch number,
sampling date/place, reference to sampling protocol used, description of containers and materials
sampled, possible abnormalities, any relevant observations, name/signature of the sampler.

 Store the sample in a properly labelled container : sample type, name of material, identification
code, batch number, code, quantity, date of sampling, storage conditions, handling precautions,
container number.
SAMPLE STORAGE
& RETENTION
 Containers

Containers used to store a sample should comply with the storage directions for the active
pharmaceutical ingredient, excipient or drug product:
- should not interact with the sampled material.
- should not allow contamination.
- should protect the sample from light, air and moisture.
- should be sealed and adequately labelled.
- avoid mix-up when containers are opened (screw caps, separate lids).
- manipulations/unauthorised opening should be easy detectable.
transported in such way as to avoid breakage.
SAMPLE STORAGE
& RETENTION
Rooms for sample storage

- Security and adequate storage conditions (light, ventilation, safety requirements, and any
special requirements) should be ensured for the rooms in which samples are stored.

- Samples should be stored according to the storage conditions as specified for the respective
API, excipient or drug product.

- Packaging materials similar to those in which the bulk is supplied should be used for long-
term storage.
Assignment
Sample of Different Containers in Pharmaceutical products
THANK YOU!

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