SOP

Recent Posts

Tablets In Pharma Industry

Tablets In Pharma Industry NOTE- The provisions of this monograph do not necessarily apply to tablets intended for use other than by oral administration such as Vaginal preparations or Or mucosal preparations, and to lozenges, oral pastes and oral gums. Introduction Tablets are solid dosage forms each containing a unit …

Read More »

CAPSULES IN PHARMA INDUSTRY

CAPSULES IN PHARMA INDUSTRY Capsules are solid dosage forms in which the drug substance is enclosed within either a hard or soft soluble shell. Generally, the shells are formed from gelatin. The capsule may be regarded as “container” drug delivery system, which provides a tasteless/odorless dosage form without the need …

Read More »

Total Organic Carbon in Water in Pharma Industry

Total Organic Carbon in Water in Pharma Industry This method for determining total organic carbon (TOC) indirectly measures the total· amount of organic substances present in water for pharmaceutical use in Pharma Industry. The molecules of organic matter in water are oxidised to produce carbon dioxide which is then measured …

Read More »

Disintegration Test in Pharma Industry

Disintegration Test in Pharma Industry This test determines whether dosage forms such as tablets, capsules, boluses pessaries, and suppositories disintegrate within a prescribed time when placed in a liquid medium under the prescribed experimental conditions. For the purpose of this test, disintegration does not imply complete solution of the dosage …

Read More »

Checklist for QC Audit in Pharma Industry

Checklist for Laboratory in Pharma Industry Laboratories should be audited regularly and at least once per year. Auditing is an independent activity and separate from self-inspection. Auditing activities could include reviewing SOPs, worksheets, laboratory notebooks, balance calibration records, working control data, pipette calibration records, equipment monitoring logs and other related …

Read More »

Effectiveness of Antimicrobial Preservatives in Pharma industry

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 …

Read More »

Principles of HVAC Duct Design in Pharma Industry

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 …

Read More »

Equipment in Pharma company as per USFDA

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 …

Read More »

Organization and Personnel in Pharma industry as per USFDA

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 …

Read More »

Production and Process Controls in Pharma industry as per USFDA

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 …

Read More »

Definitions as per 21 CFR 210 (USFDA) in Pharma company

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 …

Read More »

Buildings and Facilities in pharma industry as per USFDA

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 …

Read More »

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 – …

Read More »

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 …

Read More »

SOP for operation of Auto coater

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 …

Read More »

Document Management System in Quality Assurance Department in Pharma Industry

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 …

Read More »

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

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 …

Read More »

Cleaning of Rapid Mixer Granulator with Cone Mill in Pharma Industry

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 …

Read More »

SOP on cleaning of Paste Kettle in Pharma Industry

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 – …

Read More »

SOP for operation of Metal Detector in Pharma Industry

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 …

Read More »
free website promotion

Powered by themekiller.com anime4online.com animextoon.com apk4phone.com tengag.com moviekillers.com