SOP on Sampling of Raw Material Objective: To lay down the procedure for the sampling of raw material. Scope: This procedure is applicable for the sampling of raw material. Responsibility: Chemist or above Accountability: Head – Quality Control Procedure: Sampling of Raw Materials: Raw material sampling shall be initiated after receiving the “GRN” from the…
List of SOPs Quality Control Sr. No. SOP Title 1. SOP on entry & exit procedure in Quality Control Department 2. SOP on sampling of raw material. 3. SOP on intermediate and finished product analysis and approval 4. SOP on analysis of sample by contract laboratory 5. SOP on sampling procedure of packaging material. 6….
Gelatin Colour Mixer A Gelatin Colour Mixer is a semi-automatic machine used for mixing color and another additive with melted gelatin mass. The machine is provided with an in-built hydraulic system to lift / down the top lid. The top lid has an I-bolt to fix the jacketed storage vessel with it. The stirrer is…
SOP for operation of Strip Packing Machine Standard Operating Procedure (SOP) Objective To lay down a procedure for operation of Strip Packing Machine. Scope This SOP is applicable for the operation of Strip Packing Machine used to pack the Tablets and Capsules into Strips in the formulation plant. Responsibility Production Operator/ Technician shall be responsible…
Installation Qualification of Gelatin Storage Vessel To describe the Installation Qualification of the Gelatin Storage Vessel and its accessories and to define the Specification of the system to: Ensure that the equipment meets the specifications as per Design Qualification. Aid verification of the installation as per equipment general arrangement Drawing. Ensure that the system installation…
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SOP for operation of de-dusting and polishing machine Standard Operating Procedure (SOP) Objective To lay down a procedure for operation of de-dusting and polishing machine. Scope This SOP is applicable for operation of de-dusting and polishing machine used to polish the Filled Capsules in Capsule Filling Area to the formulation plant. Responsibility Production Operator/ Technician…
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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 ensure that operation of the…
SOP FOR STABILITY STUDY IN PHARMA INDUSTRY OBJECTIVE: To lay down the procedure for collection, storage and analysis of stability of samples. SCOPE: This SOP shall be applicable for stability study of samples in Quality Control Department in Pharma Industry. RESPONSIBILITY: Officers/Executive-Quality Control shall be responsible for follow that procedure. ACCOUNTABILITY: Manager- Quality Control and…
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 dose of one or more…
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 of a secondary coating step,…
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 in an instrument and from…
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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 unit or even of its…
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 items for producing test results….
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 dosage forms is to prevent…
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Principles of HVAC Duct Design in the Pharma Industry How Does a Duct System Work – The duct, or air distribution, the system used in cooling and heating your area is a collection of tubes that distribute the heated or cooled air to the different rooms in the Pharma Industry. This branching network of round…
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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 cleaning and maintenance. Equipment construction…
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 drug products, and the authority…
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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 CFR 211.111). Control of microbiological…
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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 terms apply to this part…
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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 orderly placement of equipment and…
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