SOPs

Assigning of repack before date

ABHA

Assigning of repack before date

OBJECTIVE : To lay down the procedure for assigning of ‘repack before date’.

RESPONSIBILITY : 

Officer  Production/Officer Quality Assurance

Head – Quality Assurance to ensure compliance.

PROCEDURE:

The ‘repack before date’ shall be assigned from the day packing is initiated.

The basis for period of repack before shall be on the approval given by FDA.

The period of repack before shall be mentioned in the respective Master Production Records.

(a)  When the ‘repack  before date’ is 3 months :

(i) If the date packing initiated is 15 August, 2020, then the repack before date shall be 14 November, 2020.

(ii) If the date packing initiated is 1 September, 2020, then the repack before date shall be 30 November, 2020.

(b)  When the ‘repack  before date’ is 6 months :

(i) If the date packing initiated is 15 August, 2020, then the repack before date shall be  14 February, 2021.

The date shall be in the form of DD/MM/YY.

All Post URL of Drugs formulations

ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube