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Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

SOP for cleaning of FBD bag

SOP for cleaning of FBD bag Standard Operating Procedure (SOP) Objective To lay down a procedure for cleaning of FBD bags. Scope This SOP is applicable for the cleaning of FBD bags in the formulation plant. Responsibility Production Operator/ Technician – For cleaning of the equipment. Production Officer/ Executive – …

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SOP for operation of Tablet Inspection Machine

SOP for operation of Tablet Inspection Machine Standard Operating Procedure (SOP) Objective To lay down the procedure for operation of Tablet Inspection Machine. Scope This SOP is applicable for the operation of Tablet Inspection Machine in the formulation plant. Responsibility Production Operator/ Technician – For operation of the machine. Production …

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SOP for operation of Auto coater.

SOP for operation of Auto coater Standard Operating Procedure (SOP) Objective 1.1             To lay down a procedure for operation of Auto coater. Scope 2.1             This SOP is applicable for operation of Auto coater in the formulation plant. Responsibility Production Operator/ Technician – For operation of the machine. Production Officer/Executive …

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Document Management System in Quality Assurance Department.

Document Management System in Quality Assurance Department Standard Operating Procedure (SOP) Objective: To lay down a procedure for Management of Documents in Quality Assurance Department. Scope: Applicable for Document Management system in Quality Assurance department. Responsibility: Quality Assurance Department Accountability: Head- QA shall be accountable for compliance of this SOP. …

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SOP for operation of rapid mixer granulator (RMG) with cone mill

SOP for operation of rapid mixer granulator (RMG) with cone mill Standard Operating Procedure (SOP) Objective To lay down a procedure for operation of rapid mixer granulator with cone mill. Scope  This SOP is applicable for operation of rapid mixer granulator with cone mill to the formulation plant. Responsibility Production …

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Cleaning of Rapid Mixer Granulator with Cone Mill

Cleaning of Rapid Mixer Granulator with Cone Mill Standard Operating Procedure (SOP) Objective: To lay down a procedure for cleaning of Rapid Mixer Granulator with cone mill. Scope: This SOP is applicable for the cleaning of Rapid Mixer Granulator with cone mill located in oral section at formulation plant. Responsibility: …

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SOP on cleaning of Paste Kettle

SOP on cleaning of Paste Kettle Standard Operating Procedure (SOP) Objective To lay down a procedure for cleaning of Paste Kettle. Scope This SOP is applicable for the cleaning of Paste Kettle in the formulation plant. Responsibility Production Operator/ Technician – For cleaning of the equipment. Production Officer/ Executive – …

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SOP for operation of Metal Detector

SOP for operation of Metal Detector Standard Operating Procedure (SOP) Objective: To lay down a procedure for operation of metal detector. Scope: This SOP is applicable for the operation of metal detector to the formulation plant. Responsibility: Production Operator/ Technician shall be responsible for operation of the machine. Production Officer/Executive …

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SOP on Operation of Paste Kettle

SOP on operation of Paste Kettle Standard Operating Procedure (SOP) Objective To lay down the procedure for operation of Paste Kettle. Scope This SOP is applicable for operation of Paste Kettle in the formulation plant. Responsibility Production Operator/ Technician – For operation of the equipment. Production Officer/ Executive – For …

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Contract production, analysis and other activities as per WHO Guideline

Contract production, analysis, and other activities Principle. Contract production, analysis and any other activity covered by GMP must be correctly defined, agreed and controlled in order to avoid misunderstandings that could result in a product, or work or analysis, of unsatisfactory quality. All arrangements for contract production and analysis, including …

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