sop for for Sampling of Re-testing Raw Materials for analysis
OBJECTIVE
1.1 To lay down procedure for Sampling of Re-testing Raw Materials for analysis.
2.0 SCOPE
2.1 This SOP is applicable to Re-testing Raw Materials received
3.0 RESPONSIBILITY
3.1 QC Officer or QC Executive
4.0 ACCOUNTABILITY
4.1 QC Manager
5.0 Procedure
5.1.1 Receive the GRN (Goods Received Note) from Re-testing Raw material Stores and make necessary entries in
the Re-testing raw material inward register.
5.1.2 Give the Re-testing Raw material AR.NO.
5.1.3 AR. NO should be given as follows
For Re-testing raw material: RCR-XXX/Session
Where, R= Re-Testing
CR= Certificate Raw Material
XXX= Intimation Number
Session= Year (e.g. 2020-2021 as 20-21)
5.1.4 Collect the samples as per sampling schedule.
5.1.5 After completion of sampling do the necessary test (e.g. Identification, Assay, LOD,
Water content and pH) as per the Standard Analytical Procedure.
5.1.6 Raw material may also will verify physical appearance then approved the label.
5.1.7 After completion of testing took the status of Approved/Rejected on the container.
5.1.8 Re-testing of any raw material frequency, active material 1 year and inactive material 2 years and
all Vitamin materials frequency should be 6 months.
6.0 ABBREVIATIONS
| Abbreviation | Extended Form |
| QC | Quality Control |
| SOP | Standard Operating Procedure |
| R-CR | Re-testing certificate raw material |
7.0 ATTACHMENTS
Re-testing Inward Register
8.0 REFERENCE
| Sr. No. | Reference Title |
| 01. | In-House |
sop for Calibration and Maintenance of Laboratory Instruments and Equipment
Disposal of Residual Sample or Left Over Material
sop for for Laboratory Incident
standard operating procedure temperature monitoring
sop for operation of infrared moisture balance
sop for preparation of mobile phase
sop for Preparation and Issuance of Analysis protocol standard
sop of placebo and impurity stock solutions
sop for disposal of residual sample
sop for handling of pharmacopoeial changes
sop for procedure for operation of ultrasonic cleaner
difference between UPLC and HPLC
sop for for Emergency Eyewash and Shower
sop for operation and calibration of total organic carbon analyzers
sop for operation of cobb tester
sop for Operation and calibration of atomic absorption spectrophotometer
sop for Operation and calibration of gas liquid chromatograph
sop for operation of humidity oven
sop for operation and calibration of serological water bath
sop for monitoring of drain trap
sop for destruction of analytical samples after testing and control samples
sop for destruction of used chemicals
Sop for Operation of suction pump
sop for Operation and calibration uv cabinet
sop for Operation and calibration of bulk density apparatus
sop for operation and calibration of shore hardness tester
sop for operation of rub proofness tester
sop for monitoring of purified water
sop for Retesting of packaging materials
sop for Retesting and resampling of raw materials
sop for Control of issuance of record of analysis green sheets
sop for Control of computer passwords
sop for sampling of packaging materials PM
sop for sampling of sterile raw material
sop for sampling of intermediates and finished products
sop for operation and calibration of friability test apparatus
sop for approval and rejection of packaging materials
sop for non conformance of RM PM and finished product
