Tag Archives: Syracuse

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 …

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 the 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 the Pharma Industry. This branching …

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 …