Analysis of vitamin B1 B6 B2 Nicotinamide and sodium pentothenate Injection

  Analysis of vitamin B1, B6, B2 Nicotinamide and sodium pentothenate Injection     1.0 OBJECTIVE 1.1 To lay down a procedure for Analysis of vitamin B1, B6, B2 Nicotinamide and sodium pentothenate Injection. 2.0 SCOPE 2.1 This procedure is applicable to the Analysis of vitamin B1, B6, B2 Nicotinamide & sodium pentothenate Injection. in … Read more

sop for Event Reporting and Investigation

  sop for Event Reporting and Investigation        1. Purpose:  To define procedure for event reporting and investigation.    2. Scope:   This SOP is applicable to all events which can affect the Safety, Identity, Strength, Purity and or Quality of the product which can be, 2.1 Facility related. 2.2 Utility/Service related. 2.3 Storage … Read more

Analysis for Nandrolone Decanoate injection

    Analysis for Nandrolone Decanoate injection   1.0 OBJECTIVE 1.1 To lay down a procedure for Analysis of Nandrolone Decanoate injection 2.0 SCOPE 2.1 This procedure is applicable to the Analysis of Nandrolone Decanoate injection.in QC lab 3.0 RESPONSIBILITY 3.1 Q.C- Chemist 4.0 ACCOUNTABILITY 4.1 Head-Quality Assurance    5.0 Identification: Determine by thin layer … Read more

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

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