Evaluation of Applying The Good Labratory Practice System in the Pharmaceutical Industry - Case Study of Pharmaland Company 2018

Abstract

This descriptive study was carried out in pharmaland company, during the period from January 2018 to june 2018, the study was aimed to evaluateof applying the good labratory practice system in the pharmaland company,Questionnaires were distributed to the (20) employees of the laboratories that applyGLP and then collected and analyzed using SPSS program, frequencies and percentages were calculated. The study revealed the following results: quality manager (100.0%), organizational charts(90.0%), substitutes for key management (85.0%), laboratory’s documentation responsibility (100.0%), information flow (100.0%), staff members awareness(90.0%),policy and procedure to ensure the confidentiality of the information(85.0%), Quality Manual(0.0%), top management periodic reviews (90.0%), internal quality audit(80.0%), policy for handling out-of-specification(85.0%),SOPs review (95.0%), SOPs written and approved for all testing activities (100.0%), SOPs approved by an authorized person(100.0%), SOPs available at the relevant location (95.0%), system for distribution of SOPs(100.0%),staff were trained for new and revised SOPs (95.0%), system of change control(95.0%), revised documents includes reference to previous documents (95.0%),records maintained for 2 years (100.0%), job descriptions (100.0%),SOP for identifying training needs (95.0%),staff undergoing training appropriately supervised (75.0%),training and education records available (80.0%),on the job training procedures for new employees(90.0%), formal evaluation after training (85.0%), adequate laboratory facilities(95.0%), separate storage facilities maintained for the secure storage of samples, retained samples and reagents (80.0%), environmental conditions(75.0%), access restricted to authorized personnel(0.0%), archive facilities provided to ensure the secure storage and retrieval of all documents (75.0%),reagents and chemicals used in tests and assays of appropriate quality (80.0%),reagents purchased from reputable suppliers(85.0%), reagents and solutions properly labelled(95.0%), reference standards properly stored(75.0%), procedure for qualification of secondary reference standards (85.0%), certificates of analysis from suppliers of primary reference standards available (80.0%), system for validation and regular revalidation of all equipment(45.0%), system to investigate and record all deviationsfrom specifications or malfunctioning of equipment(55.0%), equipment purchased from an agent capable of providing full technical support and maintenance (85.0%), all equipment, instruments or other devices used for testing, verification or calibration, uniquely identified (95.0%), a procedure specifying that equipment and instruments cannot be used if they were beyond the calibration due date(90.0%),software appropriately validated (0.0%),back-files(85.0%),electronic data protected from unauthorized access(80.0%),procedure for reviewing and updating security access(50.0%),procedures in place for disaster recovery (0.0%),Sample test request form (95.0%),laboratory notebook (100.0%),the notebook contain documentary evidence (90.0%),notebook signed by the responsible analysts, verified and signed by the supervisor(100.0%),analytical procedures validation(45.0%),system suitability testing(85.0%),deviations from the test procedure(80.0%),SOP for investigation of out-of-specification(95.0%),general and specific safety instructions(80.0%),safety data sheets (0.0%),smoking, eating and drinking in the laboratory (90.0%),staff wear laboratory coats or other protective clothing including eye protection(95.0%),trained in first-aid techniques, emergency care (85.0%),staff trained in the safe handling of glassware, corrosive reagents and solvents(80.0%). The study conclude that: some variables were well establish such as the organization and management, documentation , personnel, materials ,equipment and instruments ,working procedures and safety other variables were not well establish such as quality management system and computer systems .