The investigation related to quality-related events that occur from cGxPs approved specifications, and/or procedures including but not limited to Protocols, Master Batch Records (MBR), Batch Packaging Records (BPR), breakdowns, facilities, storage, distribution, manufacturing, testing, packaging, warehouse and distribution of drug products. Guideline on Investigation Tools 1.0   PURPOSE: This Standard Operating Procedure (SOP) defines the requirements […]

Standard Operating Procedure (SOP) for Handling of Raw material and Packing Material returned from different sections of the manufacturing/production department to stores/warehouse. Handling of Returned Raw and Packing Material  1.0   Purpose: To define the procedure for handling of Raw Materials and Packaging Material Returned from the production department.  2.0   Scope – SOP for Returned Material: […]

Standard Operating Procedure (SOP) and Guideline for Good Warehousing Practices for Raw Material and Packing Materials. The storage of materials in the specified areas according to the classification i.e. poison. Corrosive, Flammable, etc. Good Warehousing Practices 1.0   Purpose: The warehousing of Raw materials/packing material is an important aspect for the following reasons: Proper Identification The […]

Standard Operating Procedure (SOP) for cleaning of Pre-filters, Microvee filters, and cartridge filter of the equipment ( AHU, FDV, Autocoaters, FBD,  RLAF, LAF, and Dust Collector ) installed in the Pharmaceutical Plant. Procedure for Filter Cleaning 1.0   PURPOSE: The purpose of this SOP is to define the procedure for cleaning Prefilters, Microvee filters, and cartridge […]

Standard Operating Procedure (SOP) and Guideline for preparation, approval, and revision of Site Master File (SMF). The Site Master File (SMF) Document shall contain specific information about the quality management policies, activities of the site, the production and/or quality control, pharmaceutical manufacturing operations, and any closely integrated operations at adjacent and nearby buildings. Guideline for […]

Standard Operating Procedure (SOP) for Training of Contractual Workers in pharma, A contract worker does not become a regular addition to the staff, hired for a specific job, perform under the close monitoring/supervision company staff. Training of Contractual Worker 1.0   PURPOSE: The purpose of this SOP is to define the procedure of training for CW […]

Standard Operating Procedure (SOP) to define the detailed procedure regarding Pest & Rodent Control in Pharmaceuticals drug manufacturing plant. Pest & Rodent Control Procedure 1.0   Purpose: The purpose of this SOP is to lay down the procedure for Pest & Rodent Control treatment in the plant. 2.0   Scope: This procedure is applicable for controlling the […]

Aseptic technique is a critical requirement for collecting and testing sterile and non-sterile samples in order to avoid contamination that could provide incorrect test results. SOP for Aseptic Technique 1.0   OBJECTIVE : The objective of this Standard Operating Procedure (SOP) is to define proper aseptic a technique during microbiological sampling and testing to avoid contamination […]

Standard Operating Procedure (SOP) for Housekeeping of the different areas of Factory Premises at pharmaceutical drug manufacturing plants. Good Housekeeping Practices in Pharma Plant 1.0   PURPOSE: The purpose of this SOP (Standard Operating Procedure) is to lay down the procedure for housekeeping of the factory premises. 2.0   SCOPE – HOUSEKEEPING PRACTICES: This SOP is applicable […]

The EHS policy is a guiding principle used to set direction in an organization. It is used for a course of action to guide and influence decisions. It should be used as a guide to decision making under a given set of circumstances within the framework of objectives, goals, and management philosophies as determined by […]

Standard Operating Procedure SOP for Good Laboratory Practices (GLP) in line with the Schedule L1 requirement of the drug and cosmetic act. Good Laboratory Practices (GLP) embodies a set of principles that provides a framework within which laboratory studies (activities) are planned, performed, monitored, recorded, reported, and archived. Good Laboratory Practices (GLP) 1.0   Purpose: The […]

Safety at Workplace related to the working environment at a company and encompasses all factors that impact the safety and health of employees. This can include environmental hazards, unsafe working conditions or processes, drug and alcohol abuse, and workplace violence. Safety at Workplace – SOP for Safety Management 1.0   PURPOSE: This procedure will provide guidance […]

Standard Operating Procedure (SOP) for Handling and Investigation of Extraneous Peak(s) in Chromatography Analysis. What are the Extraneous Peaks: A peak response in the chromatogram that is not readily attributable as a characteristic of the injection profiles of the blank, mobile phase, diluting solvent, placebo, standard, or sample solutions. By definition, extraneous means introduced from […]

Standard Operating Procedure (SOP) for the handling of rejected raw materials and packing materials which are rejected due to the Non-conformance of Quality Standards, Online rejection, or Improper storage. Handling of Rejected Materials (Raw Material & Packing Material) 1.0   Purpose: To define the procedure for the handling of rejected materials (Raw Material & Packing Material). […]

Standard Operating Procedure (SOP) for reconciliation of packing materials and bulk at the end of the packing of each batch of Drug Product SOP for Reconciliation of Packing Materials 1.0   PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the detailed procedure for the reconciliation of packing materials and bulk at the […]