Pharmaceutical Guidance Complete Pharma Solution

Effectiveness of Antimicrobial Preservatives in Pharma industry The efficacy of antimicrobial preservation of a pharmaceutical preparation on its own or, if necessary, with the addition of a suitable preservative has to be ascertained during the development of the product. The primary purpose of adding antimicrobial preservatives in Pharma industry to …

Principles of HVAC Duct Design in Pharma Industry How Does a Duct System Work  The duct, or air distribution, system used in cooling and heating your area is a collection of tubes that distributes the heated or cooled air to the different rooms in Pharma Industry. This branching network of …

Equipment in Pharma company as per USFDA Equipment design, size, and location (§ 211.63) in Pharma company Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its …

Organization and Personnel in Pharma industry as per USFDA  Responsibilities of quality control unit (§ 211.22) in Pharma industry (a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and …

Production and Process Controls in Pharma industry as per USFDA Written procedures; deviations (21 CFR 211.100). Charge-in of components (21 CFR 211.101). Calculation of yield (21 CFR 211.103). Equipment identification (21 CFR 211.105). Sampling and testing of in-process materials and drug products (21 CFR 211.110). Time limitations on production (21 …

Definitions as per 21 CFR 210 (USFDA) in Pharma company (a) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in Parts 211 through 226 of this chapter for Pharma company. (b) The following definitions of …

Buildings and Facilities in pharma industry Design and construction features in pharma industry  (a) Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations. (b) Any such building shall have adequate space for the …

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 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 …