Pharmaceutical Guidance Complete Pharma Solution

Scale-up & Technology Transfer as a Part of Pharmaceutical Quality Systems The body of knowledge available for a specific product and process, including critical-to-quality product attributes and process parameters, process capability, manufacturing and process control technologies, and quality systems infrastructure. “Robustness” Is the ability of a process to demonstrate acceptable …

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 – To …

SOP for operation of Blister Packing Machine Standard Operating Procedure (SOP) Objective To lay down a procedure for operation of Blister Packing Machine. Scope This SOP is applicable for the operation of Blister Packing Machine in the formulation plant. Responsibility Production Operator/ Technician shall be responsible for operation of the …

Entry and exit of visitors through primary change room into production area Standard Operating Procedure (SOP) Objective To lay down a procedure for entry and exit of visitors through primary change room into production area. Scope This SOP is applicable to all authorized visitors entering through primary change room. Responsibility …

Entry and exit  of gents through Primary change room to production block Standard Operating Procedure (SOP) Objective: To lay down a procedure for entry and exit of gents through primary change room to production block. Scope: This SOP is applicable to all authorized employees of the formulation plant. Responsibility: All …

Test requirements & Stability studies as per WHO TRS Test requirements  as per WHO TRS Starting and packaging materials Before releasing a starting or packaging material for use, the QC manager should ensure that the materials have been tested for conformity with .specifications for identity, strength, purity and other quality …

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 – …

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 …

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 …

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. …

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 …

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: …

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 – …

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 …

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 …

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 …

Pharmaceutical Manufacturing Premises – Risk classification guide for drug good manufacturing practices observations Risk 1 (critical) observations There was no air filtration system to eliminate airborne contaminants likely to be generated during fabrication or packaging. There was generalized malfunctioning of the ventilation system(s), with evidence of widespread cross-contamination. Segregation of …

Process Validation: General Principles (USFDA) This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes. FDA encourages the use of modern pharmaceutical development concepts, quality risk management, and quality systems at all stages of the manufacturing process lifecycle. The lifecycle concept links product and process …

Management Review Objective To have a systematic approach for quality review as per Quality Management System (QMS) with a objective to monitor product quality, validated status of products and related processes, identify improvements required in manufacturing process and systems and take care of quality risks throughout product life-cycle. Scope This …

SOP on Standard Operating Procedures Objective: To lay down a procedure for preparation, review, approval, distribution, control & revision of Standard Operating Procedure. Scope: This procedure is applicable to all SOP’s of the formulation plant of Pharmaceutical Company. Responsibility: Personnel (originating department) – Preparation of SOPs. Department Head / nominee …