SOPs

Procedure For destruction & recovery generated during production

STANDARD OPERATING PROCEDURE

Title: Procedure For destruction & recovery generated during production

  • OBJECTIVE 
    • To lay down the documented Procedure for destruction & recovery generated during  production the following recover are generated.
  • SCOPE
    • This SOP is Applicable for destruction & recovery generated during production the following recover are generated.
  • RESPONSIBILITY
    • Executive – Engg. & Utility.
    • Manager-Production.                                                                                                         
  • ACCOUNTABILITY
    • Manager-Quality Assurance 
  • PROCEDURE
    • PVC/PVDC Net
    • Foil Net
    • Label
    • Carton
    • Liquid, tablet, capsule etc.
    • Rejected or obsolete foil, labels, crotons, leaflets
    • The left over net and PVC/PVDC is collected and sent to the scrap yard for the authorized scrap dealer.
    • Obsolete foil is pierced with an Iron rod to make it unusable and to the scrap yard for the authorized scrap dealer.
    • The rejected labels, crotons, leaflets are from into piece manually verified by QA & sent to the scrap yard for sale to authorized dealer.
    • The blister/strip is defoiled to remove the tablets and the net is sent to the scrap yard for the authorized scrap dealer.
    • The power rejected tablets, capsules are put in to water in a Plastic drum  and mixed in water the supernatant liquid Is drained. The left over wet powder is collected a taken to the ETP for treatment.
    • The sludge, after ETP treatment is collected this sludge carried away by a government agency from the factory premises on a fortnight by basis.
    • ABBREVIATIONS
    • ETP – Effluent Treatment plant.
    • QA            –           Quality Assurance.
  • ATTACHMENT
Sr. No.Title  Attachment No.
Material Destruction & Recovery Log
  • DISTRIBUTION LIST
Sr. No.Copy No.Department
11Quality Assurance
22Quality Control
33Quality Control – Microbiology
44Production –
55Engineering & Utility
66Personnel & Administration
77Warehouse
88VP-Plant & Operations

ATTACHMENT-I

LOGBOOK FOR MATERIAL DESTRUCTION & RECOVERY

  • Month/Year            :                                                                             Location:           
DateMaterial Name Quantity Checked By Prod.-OfficerVerified by

QA-Officer

Destroyed By

Engg.-Officer 

Verified by

Engg. In-charge

 

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