Sampling Plan of Raw Materials

1.0         Purpose      :     To provide an instruction for sampling plan of raw materials.

2.0         Objective    :      To provide a documented procedure for sampling plan of raw materials.

3.0               Scope     :     This procedure is applicable for sampling plan of raw materials in QC department of ---- Pharmaceutical Ltd, 

4.0         Responsibility  :

·       Primary: QC Chemist / QC Officer

·       Overall: QC – Incharge

5.0       Procedure     :

·       Basics of sampling plan

Ø      The sampling plan for R.M. has been divided into 2 categories, based on the type of material and vendors supplying these materials.

Ø      As a board classification the sampling plan is prepared considering the following aspects.

·       n-Plan

Ø      The material has been supplied from well-known supplier and when the material is considered uniform. Manufacturer produces only one product or multi products on campaign bases.

·       r-Plan

Ø      The material has been supplied from unknown / new supplier or when the material is considered non-uniform. The manufacturers have multi product activities.

·        Sampling plan

Ø      n–plan 

Under this plan,

o       If number of containers are less than 5, then take a sample from each container, tested for identification then make a composite sample for complete testing.

o       If number of containers are more than 5, then take a sample from √N + 1 container, tested for identification, then make a composite samples for complete testing.

o       Where, N = number of containers received.

o       For Key raw materials, take a sample from each container, tested for identification then, makes a composite sample for complete testing. List of key raw materials attached as Annexure-I

o       For solvents, take a sample from each container, check for colour and clarity then, makes a composite sample for complete testing.

Ø      r–plan 

o             For unknown / new supplier or when the material is considered non-uniform, take a sample from each container, tested for identification then, makes a composite sample for complete testing.

         Under this plan,

·        Composite Sample shall be divided in to two parts, one part is used for complete analysis and another is kept as Relation Sample.

·        Sampling should be carried out as per respective standard sampling procedure. Pooling out of the samples should be carried out under sampling booth in the sampling area.