Manufacturing & Expiration Date, Purpose :
Manufacturing & Expiration Date, The purpose of this SOP (Standard Operating Procedure) is to provide a system for assigning of manufacturing & expiration date of products manufactured in XX Pharmaceuticals Limited.
Manufacturing & Expiration Date, Scope :
All departments of XX Pharmaceuticals Limited (Both General and Sterile Block).
Definitions/Abbreviation:
[][]BMR : Batch Manufacturing Record
[][]BPR : Batch Packaging Record
[][]LPL : XX Pharmaceuticals Limited
[][]MFG. : Manufacturing Date
[][]EXP. : Expiry Date
[][]VAT : Value Added Tax
[][]IP : Indicating Price
Responsibilities:
[][]The roles and responsibility is as follows:
Executive, Quality Assurance
[][]To ensure that this procedure is followed.
Executive, Production
[][]To follow laid down procedure.
Manager, Quality Assurance
[][]To ensure implementation of the SOP.
Head of Quality Assurance
[][]Approval of the SOP.
Annexure:
N/A
Procedure:
Assigning of Manufacturing Date
[][]Determine the manufacturing date of a batch from the month and year at which manufacturing of that batch starts (i.e. dispensing). Consider the BMR issue date as starting point of a batch. So the month and year of issuing BMR will consider as manufacturing date.
[][]First 3 (three) letters of month and last 2 (two) numerical digits of year representing the manufacturing date.
[][]Assign the manufacturing date in block letters.
Assigning of Expiry Date
[][]Determine the expiry date from the manufacturing date and claimed shelf life of the product.
[][]First 3 (three) letters of month and last 2 (two) numerical digits of year representing the expiration date.
[][]Those products which have no manufacturing steps except encapsulation / filling, expiry date will be declared as the manufacturer’s claimed expiry date of the active material (i.e. pellets, ready granules, different materials for injectable etc.).
[][]When the active material of two different Lab. Control No. will use in one batch, then the expiry date of the product should be considered as like shorter expiry date of API claimed by the manufacturer.
[][]Assign the expiry date in block letters.
Example: a) When claimed shelf life is 1 years.
[][]For example: Cerolab 10 Tablet
[][]If manufacturing starts (or BMR issue) at January .
[][]The manufacturing date is JAN and expiry date is DEC of the following year
b) When claimed shelf life is 1.5 (One and half) years.
[][]For example: Cerporal PFS, 50 ml
[][]If manufacturing starts (or BMR issue) at January
[][]The manufacturing date is JAN and the expiry date is JUN of the following year
[][]Batch number, manufacturing date, expiry date and indicating price should be printed in different packaging material as following procedure:
For inner carton (if product shelf life is 1 year)
BATCH NO. : XX0001
MFG. DATE : JAN XX
EXP. DATE : DEC XX
IP (with VAT) :