SOP ON PROCEDURE FOR RAW MATERIAL TRANSFER FROM ONE MANUFACTURING SITE TO ANOTHER SITE

SOP ON PROCEDURE FOR RAW MATERIAL TRANSFER FROM ONE MANUFACTURING SITE TO ANOTHER SITE OBJECTIVE: To lay down the procedure for Raw material transfer from One manufacturing Site to another site. SCOPE:  This procedure is applicable to Raw material transfer from quarantine of warehouse. RESPONSIBILITY: It is the responsibility of warehouse other also assistant to follow … Read more

SOP ON DRESS WASHING, ISSUE & CONTROL

SOP ON DRESS WASHING, ISSUE & CONTROL OBJECTIVE: To lay down a procedure for dress code numbering, washing, issue & control. SCOPE: This Procedure is applicable for cleaning of general dress of employees working. RESPONSIBILITY: Housekeeping Supervisor/ Nominee ACCOUNTABILITY: Manager – P&A PROCEDURE: Monitoring of Garments Washing: Pre-start-up: Visually check the cleanliness of garment wash room. Check the … Read more

SOP ON PROCEDURE FOR MEDICAL EXAMINATION

SOP ON PROCEDURE FOR MEDICAL EXAMINATION OBJECTIVE: To lay down the procedure for Medical Examination of all employees. SCOPE: This procedure is applicable for Medical Examination of all employees working. RESPONSIBILITY: Officer/ Manager – Personnel & Administration. ACCOUNTABILITY: Head QA – To ensure implementation of SOP. PROCEDURE: Qualified Physician– A person having medical degree and government registered practitioner.  Medical … Read more

SOP ON OPERATION AND CLEANING OF INSECTICUTER

SOP ON OPERATION AND CLEANING OF INSECTICUTER OBJECTIVE : To lay down the procedure for operation and Cleaning of Insecticuter. SCOPE : This SOP is applicable for the operation and Cleaning of Insecticuter mounted for the protection of ancillary area with insects in the plant. RESPONSIBILITY: Officer/ Manager- Personnel & Administration – To ensure proper cleaning and operation … Read more

SOP ON PROCEDURE FOR CLOTHING & PERSONAL HYGIENE

PROCEDURE FOR CLOTHING & PERSONAL HYGIENE OBJECTIVE: To lay down the procedure for clothing and personal hygiene. SCOPE: This procedure is applicable for clothing and personal hygiene. RESPONSIBILITY: Officer/ Manager – Personnel & Administration. ACCOUNTABILITY: Head QA – To ensure implementation of SOP. PROCEDURE: Personal Hygiene: Clean outer protective clothing must be worn in all processing areas. All … Read more

SOP ON ENTRY & EXIT OF PERSONNEL IN THE FACTORY PREMISES

SOP ON ENTRY & EXIT OF PERSONNEL IN THE FACTORY PREMISES OBJECTIVE: To lay down a procedure for Entry & Exit of personnel in the factory premises. SCOPE: This SOP is applicable for Entry & Exit of personnel in the factory premises.. RESPONSIBILITY: Head of the Department – Personnel and Administration. PROCEDURE: Permanent Employees Posted at Plant: … Read more

SOP ON PEST AND RODENT CONTROL

SOP ON PEST AND RODENT CONTROL OBJECTIVE: To lay down a procedure for pest & rodent control with a view to maintain hygiene and sanitation in the factory premises. SCOPE: This SOP is applicable for pest & rodent control of following Mosquitoes, Cockroaches, Bugs, Ants, Silverfish, Rat and Lizards. RESPONSIBILITY: Officer – P&A & Administration GM Technical … Read more

SOP On Environment Monitoring (viable organisms) of Aseptic Processing areas

SOP On Environment Monitoring (viable organisms) of Aseptic Processing areas Objective:  To lay down the procedure for Environment Monitoring (viable organisms) of Aseptic Processing areas. Scope: This SOP is applicable for Environment Monitoring (viable organisms) of aseptic processing areas . Responsibility: Microbiologist or above of Microbiology Laboratory. Head – Microbiology section. Accountability: Head – Quality … Read more

SOP on Stability studies of drug products

SOP on Stability studies of drug products Objective: To lay down a procedure for carrying out stability studies of drug products. Scope: This SOP is applicable for carrying out stability studies of drug products of Responsibility: QC Chemist or above Accountability: Head – Quality Control & Head – Quality Assurance Procedure: Stability study shall be … Read more

SOP ON HANDLING AND INVESTIGATION OF INCIDENT

SOP ON HANDLING AND INVESTIGATION OF INCIDENT PURPOSE : To define the procedure for incident reporting and investigation. SCOPE : This guideline is applicable to, All incidents, which can affect the safety, identity, strength, purity and / or quality of the product which can be, Facility related. Storage related. Production related or occurred during processing. Raw / … Read more