SOP

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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 maintaining control on …

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SOP for operation and cleaning of Sterile garment cubicle

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. : …

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High-Stress Jobs may lead to Early Death: Study

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Stress at work warning signs When you feel overwhelmed at work, you lose confidence and may become angry, irritable, or withdrawn.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 …

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SOP for final packing of products.

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. : …

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SOP on cleaning and sanitization of goggles used in aseptic area

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 …

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

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 …

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Opportunities for Reducing Sampling and Testing of Starting Materials

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 …

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Generics: FDA´s New Guidance on Prior Approval Supplements

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, …

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FDA: Updated CDER List for 2016 Guidance Documents

On 8 August 2016, the U.S. Food and Drug Administration (FDA) updated the list of new and revised draft guidances CDER is planning to publish until the end of this year. The following documents are listed under the category “Pharmaceutical Quality /Manufacturing Standards (CGMP)”: Data Integrity and Compliance with CGMP …

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SOP on sterilization of garment and surgical hand gloves

Objective To lay down a procedure for sterilization of garments and surgical hand gloves. Scope This SOP is applicable for sterilization of garments and surgical hand gloves. Responsibility Production Officers /Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure. LAF : …

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WHO issues Update of Pharmaceutical Water Guideline

The current TRS 970 of the WHO also comprises an updated version of the guideline regarding the manufacture and distribution of water for pharmaceutical use as Annex 3. This revised version contains the same chapters. The modifications are rather based on comments to the previous version which were reviewed and …

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SOP on cleaning during media fill trials and decontamination after completion of media fill trials

Objective: To lay down a procedure for cleaning during media fill trial and decontamination after completion of media fill trials. Scope:  This SOP describes the procedure for cleaning during media fill trials and  decontamination after completion of media fills trials. Responsibility: Production Officers / Executive. Accountability: Production Head shall be …

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Lilly Alzheimer’s Drug Can Save Dismal Year for Pharma

Upcoming results from late-stage data will have major impact on sector By CHARLEY GRANT Updated Nov. 22, 2016 5:06 p.m. ET After a year of drama for the health-care industry, ranging from the EpiPen pricing scandal to the collapse of Valeant Pharmaceuticals International and Theranos to the unknown future of …

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SOP for cleaning and sanitization of controlled area

Objective: To lay down a procedure for cleaning and sanitization of controlled area. Scope: This SOP is applicable for cleaning and sanitization of controlled area. Responsibility: Production Officer / Executive. Accountability: Production Head shall be accountable for compliance of SOP. Abbreviations SOP : Standard Operating Procedure. S.S. : Stainless Steel …

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SOP on Batch preparation of vial filling process.

Objective: To lay down a procedure on Batch Preparation of vial filling process. Scope This SOP is applicable for batch preparation of vial filling process.. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure. RM : Raw …

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SOP on operation and cleaning of Pneumatic Lifting Table & Visual Inspection machine

Objective To lay down the procedure of operation and cleaning of Pneumatic Lifting Table & visual Inspection machine. Scope This SOP is applicable for the operation and cleaning of Pneumatic Lifting Table & Visual Inspection used in the vial decartoning room of the sterile Injectable facility. Responsibility Production officer / …

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SOP for cleaning of strapping machine

SOP for cleaning of strapping machineObjective: To lay down a procedure for cleaning of strapping machine. Scope This SOP is applicable for cleaning of Strapping machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. Procedure The cleaning of Strapping machine is to be …

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SOP for cleaning of BOPP taping machine

Objective To lay down a procedure for cleaning of BOPP taping machine. Scope This SOP is applicable for cleaning of BOPP taping machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. BOPP : Biaxial Oriented Polypropylene IPA : Isopropyl Alcohol Procedure The cleaning …

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SOP for cleaning of inkjet printing machine

Objective: To lay down a procedure for cleaning of Ink Jet printing machine. Scope This SOP is applicable for the cleaning Ink jet printing machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. Cleaning Procedure Press “ON/OFF” switch and wait for two minutes. …

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SOP for cleaning of laminar air flow units.

Objective: To lay down a procedure for cleaning of laminar air flow units. Scope: This SOP is applicable for cleaning of laminar air flow units of Dry Powder Injectable facility. Responsibility Officers or above – Production. Accountability Production Head Shall be responsible for the implementation and compliance of the SOP. …

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