Pharmaceutical Guidance Complete Pharma Solution

SOP for operation of Auto coater Standard Operating Procedure (SOP) Objective To lay down a procedure for operation of Auto coater. Scope 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 -To maintain proper …

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 in Pharma Industry Scope: Applicable for Document Management system in Quality Assurance department. Responsibility: Quality Assurance Department Accountability: Head- QA shall be accountable for compliance …

SOP for operation of rapid mixer granulator (RMG) with cone mill in Pharma Industry Standard Operating Procedure (SOP) Objective To lay down a procedure for operation of rapid mixer granulator with cone mill in Pharma Industry Scope  This SOP is applicable for operation of rapid mixer granulator with cone mill …

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

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

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

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

Contract production, analysis, and other activities in Pharma Industry 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 …

Pharma Manufacturing Premises – Risk classification guide for drug good manufacturing practices observations Risk 1 (critical) observations in Pharma Industry 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 …

Process Validation: General Principles (USFDA) in Pharma Industry 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 …

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 In Pharma Industry Objective: To lay down a procedure for preparation, review, approval, distribution, control & revision of Standard Operating Procedure In Pharma Industry. Scope: This procedure is applicable to all SOP’s of the formulation plant of  Pharma Industry. Responsibility: Personnel (originating department) – Preparation …

SOP For line clearance Objective: To lay down the procedure for line clearance of manufacturing and warehouse area. This is to ensure that the start up of any production/ process is free from previous material/ contaminants.  Scope: This SOP is applicable for line clearance of production (oral), production (Injection), and …

PREVENTIVE MAINTENANCE OF PRODUCTION EQUIPMENT OBJECTIVE; To define the procedure for preventive maintenance of production equipment. SCOPE: This procedure is applicable for preventive maintenance of production equipment. RESPONSIBILITY: This procedure is applicable for preventive maintenance of production equipment. RESPONSIBILITY: Mechanical Engineer ACCOUNTABILITY: Engineer Head ATTACHMENTS: Attachment I – Preventive maintenance …

Procedure of shutdown and startup of Facility Objective To lay down the procedure of shutdown and start-up after shutdown of Facility. Scope This SOP is applicable for procedure of shutdown and start up after shutdown of Facility in the formulation plant. Responsibility All personnel working in respective areas. Accountability Head …

SCALE UP AND POSTAPPROVAL CHANGES (SUPAC) GUIDANCE FOR INDUSTRY: A REGULATORY NOTE INTRODUCTION Technology transfer of a pharmaceutical product from research to the production floor with simultaneous increase in production outputs is commonly known as scale-up. In simple terms, the process of increasing batch size is termed as scale-up. Conversely, …

PLASTICS AS PACKAGING MATERIAL Plastics in packaging have proved useful for a number of reasons, including the ease with which they can be formed, their high quality, and the freedom of design to which they can be changed. Plastic containers are extremely resistant to breakage and thus offer safety to …

Hold-Time Studies Guideline These guidelines focus primarily on aspects that should be considered in the design of the hold-time studies during the manufacture of non-sterile solid dosage forms. Many of the principles described here also apply to other dosage forms such as liquids, creams and ointments. These guidelines do not …

Hold Time Studies Protocol of Ornidazole Tablets 500 mg Process Step – Blending/ Lubrication About 500 gms material from blended mass is kept under simulating conditions. The material is subjected to analysis for Assay of Ornidazole,Total & single impurity  and LOD at 0 day, after 7th day & after 15th day. These …