Retesting of Approved Raw Materials / Components
1.0 Purpose: This SOP describes the procedure for retesting or reexamination of the approved raw materials.
2.0 Scope: This SOP applies to all the raw materials i.e. active and inactive which are used in the manufacture of drug formulations.
3.0 Responsibility: Quality Control Chemists to ensure that the procedure is followed.
4.0 Materials and Equipment: As required.
5.0 Procedure:
5.1
During storage for long periods or exposure to air, heat or moisture might
adversely affect the materials / components. The materials shall be retested or
reexamined after storage for long periods.
5.2
Reevaluation time scales are usually developed from data provided by
manufacturer or Material Safety Data Sheets(MSDS). Except for particularly
sensitive materials, it is usual to settle for one time period – often two
years. Sensitive materials retest date may be 6 months to 12 months depending
on the nature of material.
5.3 Reevaluation
will not usually require full testing but only examination of those parameters
known to be subject to change.
5.4 For infrequently used materials, reevaluation may be delayed until the material is required.
5.5 Sensitive materials should be stored under appropriate conditions where these are specified.
5.6 An
important factor in reevaluation of the sensitive materials is the
comprehensiveness of the material specification. When reevaluating sensitive
materials the extent of changes should be considered even for parameters still
within specifications.
5.7 A further point to be considered in reevaluating the older sensitive materials is the impact on the stability of the dosage form.
Dates
|
S.No. |
Name /
Category of Raw Material (s) |
Retest
Period |
|
1. |
Clavulanate Potasssium. Cloxacillin Sodium, |
6 months |
|
2. |
All Vitamins – B1, B2, B6, B12, Niacinamide, D3, A, E, Calcium Pantothenate, |
12 months |
|
3. |
Antibiotics / Antibacterials other than listed in S.No.1 |
12 months |
|
4. |
Betamethasone, Dexamethasone, Prednisolone, Digoxin , Empty Hard Gelatin Capsules and excepients where microbial limit test is required ( starch, lactose) |
12 months |
|
5. |
Active ingredients (other than listed above at S.No. 1 to 4 ) & preservatives |
18 months |
|
6. |
Excipients like diluents, binders, disintegrating agents, colours, flavours etc. |
24 months |
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