QUALITY MANUAL QUALITY MANUAL describes one comprehensive model for an effective pharmaceutical quality system that is based on the quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements serves as the Validation Road map, setting the course, justifying the strategy, outlining the preliminary test and acceptance criteria, and documenting the necessary programs that … Read more
SOP ON CAPA (CORRECTIVE ACTION AND PREVENTIVE ACTION) PURPOSE: To lay down the standard operating procedure for Corrective Action and Preventative Action (CAPA) is a system of quality procedures required to eliminate the causes of an existing nonconformity and to prevent recurrence of nonconforming product, processes, and other quality problems. SCOPE: This SOP is applicable … Read more
SOP OF PRODUCT RECALL PURPOSE: This procedure covers transmission of information by means of a Rapid Alert between the different parties related to the recall of medicinal products, which have quality defects, including counterfeit or tampered products, when urgent action is required to protect public health. The procedure may be used also for transmission of … Read more
SOP on Cleaning, Maintenance and Calibration of Stability Chamber Objective: To lay down a procedure for cleaning, maintenance and calibration of stability chamber. Scope: This SOP is applicable for the cleaning, maintenance and calibration of stability chamber. Responsibility: QC Chemist or above AND Electrician or above Accountability: Head – Quality Control & Head – Engineering Procedure: Cleaning: Chamber shall be cleaned … Read more
SOP FOR INCIDENCE HANDLING PURPOSE: To lay down a procedure for reporting, investigation and disposition of Incidents. SCOPE: this procedure is applicable to the reporting of investigation and disposition of unplanned, uncontrolled incidents either directly or indirectly associated with Manufacturing/Packaging, or Analytical operations. RESPONSIBILITY: Observer / Concerned Department Officer shall report the Incident. Observer / … Read more
SOP on writing & approval of Qualification and validation protocol & reports Objective: To describe the procedure for writing & approval of qualification and validation protocols & reports. Scope: This SOP is applicable to all type of qualification and validation protocol & report for all department to Formulation plant. Responsibility: The officer / executive / section in-charge … Read more
SOP FOR CLEANING VALIDATION PURPOSE: To describe the procedure for Cleaning Validation studies to be followed for equipment/ accessories used in manufacturing. SCOPE: This SOP is applicable for documented evidence and actual experimental data that the procedure being followed for cleaning of equipment and accessories is effective and removes all residues of previous product up to … Read more
SOP FOR HANDLING OF ON-LINE REJECTIONS PURPOSE: To lay down the procedure for On-line rejected materials. SCOPE: This SOP is applicable to all Raw and packing materials. RESPONSIBILITY Production officer or Executive shall be responsible to initiate online rejection note QA personnel shall issue online rejection note. IPQA personnel shall verify online rejection note. QA head/ … Read more
SOP FOR PROCEDURE FOR NUMBERING, CLEANING AND SANITIZATION OF DRAIN POINTS PURPOSE: The purpose of this Standard Operating Procedure is to provide guidance for numbering, cleaning and sanitization of drain points. SCOPE: This procedure is applicable for numbering, cleaning and sanitization of drain points of all department. RESPONSIBILITY: Preparation of SOP: Officer/ Sr. Officer … Read more
SOP FOR PROCEDURE FOR CLEANING AND DISINFECTION OF AREA PURPOSE: To lay down the procedure for cleaning and disinfection of area. SCOPE: This procedure is applicable for cleaning and disinfection of classified and unclassified area. RESPONSIBILITY: Respective user department shall be responsible to prepare the disinfectant and clean the area according to the procedure defined in the SOP. … Read more