Cleaning of Processing Cubicles or Areas

  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 Breakdown Maintenance

  sop for Breakdown Maintenance   1.0 PURPOSE To define a procedure for handling of breakdown maintenance of equipment/ instrument. 2.0 SCOPE 2.1 This procedure applies to all the equipments instruments and utility equipments 3.0  REFERENCE 3.1 References 3.1.1 In-House 3.2 ANNEXURE 3.2.1 Annexure-I        : Breakdown maintenance intimation slip. 3.2.2 Annexure-II    … Read more

sop for Responsibilities of Quality Assurance

  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

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

    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

  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

Analysis of Dicyclomine and Diclofenac sodium Injection

  Analysis of Dicyclomine and Diclofenac sodium Injection   1.0 OBJECTIVE 1.1 To lay down a procedure for Analysis of Dicyclomine and Diclofenac sodium Injection. 2.0 SCOPE 2.1 This procedure is applicable to the Analysis of Dicyclomine & Diclofenac sodium Injection. in QC lab 3.0 RESPONSIBILITY 3.1 Q.C- Chemist 4.0 ACCOUNTABILITY 4.1 Head-Quality Assurance 5.0 … Read more

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