SUMMER INTERNSHIP PROGRAM 2022 NAME: Asma Sultan DEPARTMENT: Quality Assurance DEGREE: Pharm-D JOINING DATE: 06th/June/2022 DATE OF ENDING: 15th/July/2022 TABLE OF CONTENT S.NO 1 2 3 4 5 CONTENTS Introduction of the company Details of internship Internship experience 5 key learnings Project summary “INTRODUCTION OF THE COMPANY” HISTORY: It was founded in 1995 and is one of the leading pharmaceutical companies in Pakistan. It has more than 60 brands and over 1000 employees. Its products are manufactured in Karachi at its cGMP compliant manufacturing plant. As of 2016, Martin Dow had six manufacturing facilities in Pakistan and one in France. MISSION: To be one of the most admired companies To be among the fastest growing healthcare companies VISION: Martin Dow is a Corporate Force that is positioned to create long term value for society and its stakeholders VALUES: We build products we are proud of We are passionate, agile, and courageous We believe that there’s always room for better We focus on patients’ wellbeing, and everything follows We are here to improve the quality of life for the communities we serve We create opportunities for all our partners to flourish PRODUCTS: Evion Sangobion Neurobion Polybion Glucophage Enflor Duvel Plus Rocephin Cal One-D Rivotril Musidin Lexotanil Inspra Esomax Dilatrend Elixaban Orpase Dowmoxi Safepram Kytril Bon One Malcifer-F Fusiderm Terbin Dormicum Dowmoxi Orzit Inspra Dowfylin DEPARTMENTS: Warehouse Quarantine area Finish good store Production department Quality control department Quality assurance Product development Engineering department “DETAILS OF INTERNSHIP” COMPANY NAME: MARTIN DOW MARKER. LTD DEPARTMENT: QUALITY ASSUARANCE SUPERVISOR’S NAME: HAROON MAZHAR DESIGNATION: SUMMER INTERN JOINING DATE: 06th/June/2022 DATE OF ENDING: 15th/July/2022 “QUALITY ASSUARANCE” The sum of all activities and responsibilities required to ensure that the medicine that reaches the patient is safe, effective, and acceptable to the patient. QA KEY ROLES: Line Clearance including Pre-line clearance, Onward Line Clearance and Post-Line Clearance. In Process Control. Sampling includes Retention Sample, Stability Sample and Micro Testing Sample QA GENERAL CHECKS: To ensure the cleaning of the cubicle and verify the Temperature, Pressure, Relative Humidity and LUX. To ensure the personnel hygiene, cleanliness and appropriate gowning. To ensure the update of material, status board and documents according to the current working process and progress. To perform testing according to the area. QA CHECKS IN DISPENSING AREA: QA general checks. IPC and line clearance. Ensure the additional gowning during dispensing. Verify the net quantities of all dispensed materials with QC approved label. Verify the dispensing slip and printed generated weighing slip. Verify the Manufacturing Order. QA ROLE IN GELATIN FORMATION: Line clearance Check temperature of melter. Brix value of gelatin MEDICINE MIXING & QA CHECKS: Line clearance. Addition of VitB12 is done under a QA officer. Check temperature. QA ROLE IN ENCAPSULATION: QA general checks Line clearance Weight Variation of Capsules ( fill weight, shell weight, total weight) Ribbon thickness Content Uniformity Temperature Relative humidity DRYING & QA CHECKS: Drying is a mass transfer process consisting of the removal of water or another solvent by evaporation from a solid, semi-solid or liquid. This process is often used as a final production step before selling or packaging products. In martin Dow tumblers & drying pans are used for drying. Cotton cloth (absorbent) is also added to remove the lubricant oil from the capsule. & this cloth is changed after reasonable intervel. It usually take 18-24 hours for capsules to dry. In drying QA officer will check: Line clearance. Temperature. Relative humidity. Loss on drying (limit: NMT 3%) QA ROLE IN PACKAGING AREA: Perform Line Clearance. Perform IPC (Weigh test, Leak test, Challenge test, Optical Inspection) Documentation of all performed functions and recording of data. Maintenance of BPR and Logbook. VALIDATION: Validation is the procedure which authorizing documentary evidences that prove, the following process/ method or activity will consistently produce the product which leads to the expected result (predetermined requirements) TYPES OF VALIDATION: Prospective validation (or premarket validation) Retrospective validation. Concurrent validation. Revalidation. VALIDATION MASTER PLAN: The validation master plan is a high-level document that establishes an umbrella validation plan for the entire project and summarizes the manufacturer’s overall philosophy and approach. It provides information on the manufacturer’s validation work programme and defines details of and timescales for the validation work to be performed, including a statement of the responsibilities of those implementing the plan. WAREHOUSE: It receives the raw material from the market until it has been declared as cleared it remains in the warehouse. Temperature and humidity is kept under control to prevent product degradation. It is well laid tidy and clean it has good preservation techniques for raw materials, packaging materials and finished goods. Proper documentation for material record . QUARANTINE AREA: All the raw material , packaging material and labelling materials are kept in this area during the testing period and sample has the tag of quarantine. Temperature sensitive products are kept in separate area to prevent their deterioration. FINISHED GOOD TRANSFER: All the finished product after being complied with the specifications and by complete testing is transferred to finished good transfer hall to the warehouse with the green tag (released) to be marketed, in case of any rejection the sample is marked by red tag mentioned as rejected and taken for re-testing. KEY LEARNINGS FROM THE INTERVENTION DURING THE INTERNSHIP PROGRAM: PLANT VISIT: 1) It provides the opportunity to learn practically through interaction, working methods and employment practices. 2) A plant tour provides an opportunity to observe how work actually gets done. 3) Description of how work flows are managed. 4) It gives an exposure to current work practices as opposed to theoretical knowledge. 5) Interact and learn from experts in the industry CAREER COUNSELING SESSION: 1) 2) 3) 4) 5) You clarify your career goals. It helps you understand your career options. You determine your strengths and weaknesses. You learn key skills. You broaden your perspective. DREAM SESSION: 1) Don’t give up on your dreams. 2) 3) 4) 5) Believe in yourself. All our dreams can come true if we have the courage to pursue them. You’ve got to follow that dream, wherever that dream may lead. Self-belief and hard work will always earn you success. RESUME BUILDING AND HOW TO ACE AN INTERVIEW WORKSHOP: 1) Always provide accurate, concise and realistic information. 2) Avoid mentioning unrelated work experience and hobbies. 3) Always update your resume, avoid outdated or missing contact information. 4) In any interview, avoid going without any research, dressing inappropriately or turning up late. 5) Avoid unclear answers and rambling. PROJECT SUMMARY: During my internship, I’ve gained experience to the QA, production and warehouse department of Martin Dow Marker. Ltd. The journey has been exciting and eye-opening. I’m very thankful to all the incredibly intelligent people that I have met along the way. I would like to express my sincere gratitude to ma’am Dania Shahab for smooth on boarding and organizing this highly efficient learning program for students & for their support and encouragement throughout my internship.