Month: November 2016

Installation qualification protocol for air handling unit and air distribution system

Posted on By Pharma Editor

Installation qualification protocol for air handling unit and air distribution system OBJECTIVE The objective of this protocol is to provide an outline for the inspection of static attributes, written procedure and  guidelines and respective acceptance criteria for the Installation and Operational Qualification of Air handling unit . The Air-Handling unit caters to:- AREA DETAILS – Name…

Read More “Installation qualification protocol for air handling unit and air distribution system” »

Validation & Qualification

SOP on cleaning of production area footwears.

Posted on By Pharma Editor

Objective The SOP describes cleaning procedure for footwear used in production area. Scope This SOP is applicable for the cleaning procedure for footwear used in production area. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations IPA  :  Isopropyl alcohol Description Cleaning of the section footwears is…

Read More “SOP on cleaning of production area footwears.” »

Production

SOP for operation, cleaning and maintenance of Fogger.

Posted on By Pharma Editor

Objective To lay down the procedure for operation, cleaning and maintenance of Fogger. Scope This SOP is applicable for the operation, cleaning and maintenance of Fogger used in the Aseptic area of Sterile Injectable Facility. Responsibility Production officer / Executive. Accountability Production Head shall be accountable for compliance of SOP. Abbreviations SOP : Standard Operating…

Read More “SOP for operation, cleaning and maintenance of Fogger.” »

Production

SOP on sterilization of vial filling and bunging machine parts

Posted on By Pharma Editor

Objective: To lay down a procedure for sterilization of vial filling and bunging machine parts. Scope This SOP is applicable for sterilization of vial filling and bunging machine parts. Responsibility Production Officers/ Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure. Procedure Controlled Area Operation. Load…

Read More “SOP on sterilization of vial filling and bunging machine parts” »

Production

SOP for Operation of Vacuum Leak Test

Posted on By Pharma Editor

Objective: To lay down a procedure for operation of vacuum leak test Scope: This SOP is applicable for operation of vacuum leak test. Responsibility: Production Officers / Executive. Accountability: Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure MMI : Man Machine Interface NST : Non sterile side…

Read More “SOP for Operation of Vacuum Leak Test” »

Production

SOP on cleaning of Pre-filters of LAF Unit, Sterile Garment cubicle, Dynamic pass box.

Posted on By Pharma Editor

Objective: To lay down a procedure for cleaning of the pre-filters of LAF Unit, garment cubicle, dynamic pass box. Scope This SOP is applicable for cleaning of pre-filters of LAF Unit, garment cubicle, dynamic pass box. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP :…

Read More “SOP on cleaning of Pre-filters of LAF Unit, Sterile Garment cubicle, Dynamic pass box.” »

Production

SOP for disposal of rejected primary and secondary packing materials

Posted on By Pharma Editor

Objective: To lay down a procedure for Disposal of rejected primary & secondary packing materials. Scope This SOP is applicable on procedure for Disposal of rejected primary & secondary packing materials for Production dry powder Injection facility. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. WFI : Water…

Read More “SOP for disposal of rejected primary and secondary packing materials” »

Production

SOP On Installation, Operational and Performance qualification of Equipment

Posted on By Pharma Editor

OBJECTIVE :      To lay down the procedure for Installation, Operation and Performance qualification of Equipment. RESPONSIBILITY :             Validation team comprising of representatives from functional department,   Engineering department and Quality Assurance department. Head – QA, Head – Engineering and Head of the concerned department to ensure compliance. PROCEDURE    Any equipment or instrument purchased shall…

Read More “SOP On Installation, Operational and Performance qualification of Equipment” »

Quality Assurance, Uncategorized

Preparation, Approval and Control of Standard Cleaning Procedures for equipments

Posted on By Pharma Editor

Preparation, Approval and Control of Standard Cleaning Procedures for equipments OBJECTIVE :             To  lay  down  the  guidelines  for  the  preparation,  approval and control of Standard Cleaning  Procedure (SCP) for all the applicable equipments. RESPONSIBILITY :     All the personnel  involved in the cleaning of equipments. Heads of concerned departments to ensure compliance. PROCEDURE Every   equipment …

Read More “Preparation, Approval and Control of Standard Cleaning Procedures for equipments” »

Quality Assurance

Blend uniformity

Posted on By Pharmaceutical Guidanace

BUA is an in-process test that is useful for ensuring the adequacy of the mixing of active pharmaceutical ingredients (APIs) with other components of the drug product. Definition Blend Uniformity (in accordance with FDA Guidance for Industry, ANDAs: Blend Uniformity Analysis, 1999) In-Process Control Scope BUA or homogeneity testing can be applied to all dosage…

Read More “Blend uniformity” »

Uncategorized

SOP on Assembly of cartridge filter in housing.

Posted on By Pharma Editor

Objective: To lay down a procedure on assembly of cartridge filter in housing. Scope This SOP is applicable for assembly of cartridge filter in housing. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. WFI : Water For Injection Procedure Close the valve of compressed air or Nitrogen Line…

Read More “SOP on Assembly of cartridge filter in housing.” »

Production

SOP for collection and disposal of waste & rejected material from plant

Posted on By Pharma Editor

Objective: To lay down a procedure for collection and disposal of waste & rejected material from plant. Scope: This SOP is applicable for collection and disposal of waste & rejected material from plant. Responsibility: Officers or above – Production. Accountability: Production Head. Abbreviations SOP : Standard Operating Procedure. S.S. : Stainless Steel WFI : Water…

Read More “SOP for collection and disposal of waste & rejected material from plant” »

Production

SOP On Document and Data Control

Posted on By Pharmaceutical Guidanace

SOP On Document and Data Control Objective: To lay down a procedure for control of documents and documented data. Scope: This Standard Operating Procedure is applicable for the control of documents and documented data at the formulation plant of Pharmaceuticals Company Name with Location. Responsibility All HODs shall be responsible to follow this SOP for…

Read More “SOP On Document and Data Control” »

Quality Assurance

SOP for operation and cleaning of Sterile garment cubicle

Posted on By Pharma Editor

Objective: To lay down a procedure on operation and cleaning of sterile garment cubicle. Scope This SOP is applicable for the operation and cleaning of sterile garment cubicle. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. LAF :  Laminar air flow U.V. :  Ultra violet Procedure Operation: Sterile…

Read More “SOP for operation and cleaning of Sterile garment cubicle” »

Production

High-Stress Jobs may lead to Early Death: Study

Posted on By Pharmaceutical Guidanace

Tips for Getting Your Stress under Control for Good Stress at work warning signs When you feel overwhelmed at work, you lose confidence and may become angry, irritable, or withdrawn. Other signs and symptoms of excessive stress at work include: 1.     Feeling anxious, irritable, or depressed 2.     Apathy, loss of interest in work 3.     Problems…

Read More “High-Stress Jobs may lead to Early Death: Study” »

Uncategorized

SOP for final packing of products.

Posted on By Pharma Editor

Objective: To lay down a procedure for final packing of products Scope This SOP is applicable for final packing of products for Production dry powder Injection facility. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. BOPP : Biaxial Oriented Poly Propylene. MFG. : Manufacturing EXP. : Expiry Procedure…

Read More “SOP for final packing of products.” »

Production

SOP on cleaning and sanitization of goggles used in aseptic area

Posted on By Pharma Editor

Objective: To lay down a procedure for cleaning and sanitization of goggles used in aseptic area. Scope This SOP is applicable for procedure of cleaning and sanitization of goggles used in aseptic area. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure….

Read More “SOP on cleaning and sanitization of goggles used in aseptic area” »

Production

Comprehensive Data Manipulation: New FDA Warning Letter for European Medicinal Product Manufacturer

Posted on By Pharmaceutical Guidanace

Source :GMP News 16/11/2016 During its inspections, the FDA has been observing insufficient data integrity quite often in the Far East. Now, European production sites are not always exemplary. A Warning Letter recently published for the Czech Company Interpharm Praha describes considerable deficiencies in the area of quality control with regard to API and finished products…

Read More “Comprehensive Data Manipulation: New FDA Warning Letter for European Medicinal Product Manufacturer” »

Uncategorized

Opportunities for Reducing Sampling and Testing of Starting Materials

Posted on By Pharmaceutical Guidanace

Source : GMP News 09/11/2016 Chapter 5 of the EC GMP Guide for the area of production was already updated last year. However, not everybody really knows that it contains concrete information about the conditions when testing and sampling of APIs and excipients can be reduced. Particularly sections 5.35 and  5.36 include requirements and thus show possibilities…

Read More “Opportunities for Reducing Sampling and Testing of Starting Materials” »

Uncategorized

Generics: FDA´s New Guidance on Prior Approval Supplements

Posted on By Pharmaceutical Guidanace

On October 14, 2016, the US Food and Drug Administration (FDA) published a new Guidance regarding Prior Approval Supplements (PAS). FDA says that “this guidance is intended to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs)”. Specifically, the guidance describes how the…

Read More “Generics: FDA´s New Guidance on Prior Approval Supplements” »

Uncategorized