The purpose of this SOP is to describe the procedure for the maintenance storage and usage of the Primary standards.
This SOP is applicable for all primary standards, used in Quality Control Department at manufacturing facility of Pharmaceutical Industry
PROCEDURE:
Whenever any primary standard received from supplier, check whether the sealing of the bottle is proper, and that particular material is having proper Certificate of analysis.
File the Certificate of analysis of the supplier properly.
Record the ‘date received and the ‘quantity received’ in the format as per Annexure-I.
Primary standards may be used for standardization of volumetric solutions, calibration of analytical Instruments, performance checking and for routine analysis as applicable in a quality control laboratory.
Whenever the material is needed for analysis, record the quantity of the material taken for analysis, in the concerned format as per Annexure-I.
Seal the material properly after use and keep it in the original position. Each primary standard shall be kept in laboratory condition i.e. 25°C + 2°C in original pack.
Expiry date of the primary standard shall be five years from the date of opening, or as per manufacturer’s certificate of analysis.
It shall be labeled as per Annexure- II.
Primary standard control number shall be assigned as follows
i.e. XX/PS/001
Where ,
XX=Company Name
PS= Primary Standards
001= stands for an incremental number
Refer Annexure-III for list of primary standards and primary standard shall be dried before use wherever applicable as per (Refer Annexure-IV).
TRAINING:
As per SOP of Employee Training
DISTRIBUTION:
As per SOP on SOP
ANNEXURE:
Annexure-I : Primary Standard usage record.
Annexure-II : Primary standard usage label.
Annexure-III : List of Primary standard.
Annexure-IV : Drying Condition For Primary Standard.
REFERENCES:
Nil