Cleaning of Processing Cubicles or Areas 1.0 PURPOSE To define a procedure for cleaning the Product Processing Cubicles or Areas used for production, dispensing and storage activities. 2.0 SCOPE 2.1 This procedure applies for cleaning the Product Processing Cubicles or Areas used for production, dispensing and storage activities 3.0 REFERENCE 3.1 References … Read more
sop for Responsibilities of Quality Assurance 1.0 OBJECTIVE: To lay down a Procedure to define Role and Responsibilities of Quality Assurance Department. 2.0 SCOPE: This SOP is applicable to define the Role and Responsibilities of Quality Assurance Department 3.0 RESPONSIBILITY: QA Officer/ Executive 4.0 ACCOUNTABILITY: Head QA: Approval 5.0 PROCEDURE: 5.1 Responsibilities … Read more
sop of external audits at the site 1.0 OBJECTIVE: To lay down a Procedure for handling of external audits or inspections from Regulatory agency, Customer. 2.0 SCOPE: This SOP is applicable for handling of external audits or inspections from Regulatory agency, Customer 3.0 RESPONSIBILITY: 3.1 QA (Officer/ Executive): Preparation, Distribution (to Respective Departments), Revision, Retrieval … Read more
cip of mixing vessel and holding vessel 1.0 OBJECTIVE: To lay down the procedure for Cleaning of Mixing Vessel/Holding Vessel, Cartridge Housing and Filter Housings and Pipe lines using CIP. 2.0 SCOPE: This SOP is applicable to Cleaning of Mixing Vessel, Holding Vessel, Cartridge Housing and Filter Housings and Pipe Lines using CIP … Read more
sop for batch manufacturing 1.0 OBJECTIVE: To lay down a procedure for Batch Manufacturing. 2.0 SCOPE: This SOP is applicable for Batch Manufacturing in production area 3.0 RESPONSIBILITY: Officer/Executive Production 4.0 ACCOUNTABILITY: Head Production 5.0 PROCEDURE: 5.1 PRECAUTIONS: 5.1.1 Always follow manufacturing instructions according to the respective BMR. 5.1.2 Prepare One Batch … Read more
sop for placebo batch 1.0 PURPOSE To provide a procedure for numbering, manufacturing and packing of placebo batch and control to be followed for placebo batch. 2.0 SCOPE 2.1 Applicable to all placebo batches 3.1 References In house 3.2 Attachments 3.2.1 Attachment- I : Batch Manufacturing Record of Placebo Batch for Analytical … Read more
sop for Cleaning of Ampoule Filling and Sealing Machine 1.0 OBJECTIVE: To lay down a Procedure for Operation and Cleaning of Ampoule Filling and Sealing Machine. 2.0 SCOPE: This SOP is applicable for Operation and Cleaning of Ampoule Filling and Sealing Machine, Twelve Heads, in Production 3.0 RESPONSIBILITY: Officer Production 4.0 ACCOUNTABILITY: … Read more
sop for Fogging in Sterile and Non Sterile Area 1.0 OBJECTIVE: To lay down a procedure for Fogging in Sterile and Non Sterile Area. 2.0 SCOPE: This SOP is applicable for Fogging in Sterile and Non sterile Area using Fogging Machine 3.0 RESPONSIBILITY: Officer/Executive Production 4.0 ACCOUNTABILITY: Head Production 5.0 PROCEDURE: 5.1 … Read more
Sop for Inward Outward register in Production 1.0 OBJECTIVE: To lay down the procedure Making entries in inward and Outward register in production. 2.0 SCOPE: This procedure is applicable for Making entries in inward and Outward register in production. 3.0 RESPONSIBILITY: Officer /Executive/Assistant Manager Head Production: To ensure execution and compliance. Head … Read more
sop for for Filtration of Bulk Solution 1.0 OBJECTIVE: To lay down a procedure for Filtration of Bulk Solution. 2.0 SCOPE: This SOP is applicable for Filtration of Bulk Solution in Production Area 3.0 RESPONSIBILITY: Officer / Production Manager 4.0 ACCOUNTABILITY: Head Production 5.0 PROCEDURE: 5.1 Clean the Cartridge Filter Housing … Read more