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 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 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
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 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 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 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 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 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
SOP ON CORRECTIVE ACTION AND PREVENTIVE ACTION (CAPA) PURPOSE : This Standard operating Procedure (SOP) provides the requirements for identification, evaluation, implementation, effectiveness monitoring, closure and documentation of Corrective Actions and Preventive Actions (CAPA). The CAPA system is designed to address continuous improvement of Quality Systems. SCOPE : This procedure is applicable for all Corrective and Preventive … Read more