Assigning of manufacturing and expiry date

This Document describes (Standard Operating procedure) SOP for Assigning of manufacturing and expiry date to Batch Product.

SOP for Assigning of manufacturing and expiry date to Batch Product.

I. Purpose & Scope:

• The purpose of this SOP is Assigning of manufacturing and expiry date to Batch Product.
• This Standard operating procedure shall be applicable for Assigning of manufacturing and expiry date to Batch Product.

II. Responsibilities:

• All Quality Assurance personnel shall be responsible to follow and implementation of assigning of manufacturing and expiry date to Batch Product.

III: Introduction and Procedural Part:

Procedure for assigning of manufacturing and expiry date to Batch Product:

Assigning Manufacturing Date and Expiry date on Batch Manufacturing Record (for Tablets, Capsules and External Preparations):

• Manufacturing Date on Batch manufacturing record (BMR) shall be denoted in numerical format as MM/YYYY (where MM denotes two digit of Month and YYYY denotes four digit of Year)
• e.g. BMR is issued on 19^th September 2021, then MFG date of the batch shall be assigned as 09/2021 in Batch manufacturing record.
• Expiry Date on Batch manufacturing record (BMR) shall be denoted in MM/YYYY (where MM denotes two digit of Month and YYYY denotes four digit of Year)
• e.g. BMR is issued on 19^th September 2021, then EXP date of the batch shall be assigned as 08/2024 in Batch manufacturing record in case of 36 month self life.

Assigning Manufacturing Date on Batch Packing Record (For Tablets, Capsules and External Preparations):

• Manufacturing date on batch packing record shall be denoted in following format as per customer requirement.
• MM/YYYY (where MM denotes two digit of Month and YYYY denotes four digit of Year)
• or
• DD/MM/YYYY (where DD Denotes two digit of date, MM denotes two digit of Month and YYYY denotes four digit of Year (as per DAVA portal requirement)
• In case of manufacturing date required to be assigned is in MM/YYYY format then manufacturing date on the BPR shall be the same as denoted in BMR.
• e.g. BMR is issued on 16^th September 2020 and manufacturing date denoted in BMR is 09/2020 then manufacturing date to be assigned on the BPR is same as BMR i.e. 09/2020.
• In case of country specific requirement, if manufacturing date required to be assigned is in DD/MM/YYYY format then the manufacturing date on the BPR of the batch shall be the date of dispensing of raw material as per BMR.
• e.g. BMR is issued on 19^th September 2021 and dispensing of raw material is started on 21^th September 2021 then Manufacturing date to be assigned on the BPR shall be as 21/09/2021 irrespective of the issuance date of BMR or BPR.

Assigning Expiry Date on Batch Packing Record (For Tablets, Capsules and External Preparations):

• The expiry date of finished product shall be as per the shelf life of the product (given in master formula).

Assigning expiry date (For Tablets, Capsules and External Preparations) :

• Expiry of the finish product shall be assigned as per marketing authorization/ as per country specific registration as assigned by the regulatory department in following format,
• MM/YYYY (where MM denotes two digit of Month and YYYY denotes four digit of Year), if Manufacturing Date on BPR has been assigned in the MM / YYYY format or
• DD/MM/YYYY (where DD Denotes two digit of date, MM denotes two digit of Month and YYYY denotes four digit of Year (as per DAVA portal requirement) if manufacturing Date on BPR has been assigned in DD/MM/YYYY format.
• In case of manufacturing date assigned for product with shelf life 36 months is in MM/YYYY format and BMR is issued on 19^th September 2021, then MFG date of the batch shall be assigned as 09/2021 and for the same expiry date shall be assigned as 08/2024.
• In case of manufacturing date assigned for product with shelf life 36 months is in DD/MM/YYYY then the manufacturing date of the batch shall be the date of dispensing of raw material as per BMR e.g. BMR is issued on 19^th September 2021 and dispensing started on 21^th September 2021 then MFG date of the batch shall be assigned as 21/09/2021 and for the same the expiry date shall be 20/09/2024.

Assigning of manufacturing date on BMR and BPR (for Sterile Dry Powder Injections):

• Manufacturing date shall be denoted in following format,
• DD/MM/YYYY (where DD Denotes two digit of date, MM denotes two digit of Month and YYYY denotes four digit of Year
• e.g. If BMR is issued on 19^th September 2021, then MFG date of the batch shall be assigned as 19/09/2021
• Batch Manufacturing Record (BMR) issuance date will be date of manufacturing for respective batch.

Assigning expiry date (For Dry powder Sterile Injection):

• Expiry date shall be denoted in format
• DD/MM/YYYY (Where, DD Denotes two digit of date, MM denotes two digit of Month and YYYY denotes four digit of Year)
• e.g. If BMR is issued on 19^th September 2021, then MFG date of the batch shall be assigned as 19/09/2021 and for the same expiry date shall be assigned as 18/09/2024 in case of 36 month self-life of product.
• Shelf life of product shall be reduced based on the shelf life of the API for the sterile dry powder Injection products.
• Products having multiple active ingredient(s) shall have expiry of the API having the least expiry.
• Manufacturing date shall be mentioned as “Mfg. Date” or “MFD.”
• Expiry Date shall be mentioned as “Exp. Date” or “EXP”.

Note : Assigning of manufacturing and expiry date to Batch Product by only QA personnel.