Quality Assurance Parameters to manufacture CAM / TM

1. Quality AssuranceParameters to manufactureCAM / TM Dated: 21st-Jan-2014 At Hajvery University, Lahore Presented By: Amanullah Bismil Consultant Homoeopathician

3. External Environment • Manufacturing project, with regard to the external environment, should be • Well maintained. • Free from unsanitary environmental conditions, objectionable odor, air, earth and water pollution, filth, sanitation hazards, insects and vermin.

4. Internal Environment • The internal premises must be well drained. • Present and anticipated zoning restrictions should be adequately stringent to prevent the unsuitable conditions from occurring. • Water, waste removal, electricity, fuel, service and utility deliveries must be easily obtainable right now – and for future possible growth. An adequate transportation access and sufficient parking facilities. • All the walls, floors and ceilings must be constructed of hard, nonporous and non shedding material; the material should be able to stand with hot water and detergent cleaning operations.

5. Internal Environment • Surfaces must be free from any hole or crack, wall must be flat and free of peeling paints. The maintenance/ painting schedule must be logged with the sanitation supervisor. • In the production premises air curtain must be placed and even the insecticuter should also be hanged in different areas.

6. Production Areas • Production area should be adequate in size, design and constructed to provide controlled movement and storage of materials, as well as for contamination-free processing. All manufacturing, packaging, storage, and holding space maintained in a clean and orderly fashion to minimize the possibility of errors. • There should be an orderly placement of machinery, equipment and materials to minimize the possibility of problems. • The manufacturing process in the premises should be designed line wise to minimize the possibility of error and the machinery/ equipments are placed accordingly. • No unauthorized personnel should be allowed to enter into the other department except prior permission.

7. Production AreasContinued …… • In production premises, special areas should be marked for temporary storage of raw material/in process packaging/components and after completion of the production, special places should also be marked for placing of the finished good products temporarily. And special labeled containers should be placed, where the rejected/wasted material/components are temporally stored prior to disposition, to preclude the possibility of their use in manufacturing or packing procedure for which they are unsuitable. • In the production and processing premises, eating, drinking, spitting and smoking should absolutely be prohibited. • Tissues, dusters and closed disposal container should readily be available.

8. Production AreasContinued …… • Lavatories and lockers should adequately be available, separated from the production premises. For the employees where required. • There should be a sanitation department, which should be responsible for daily cleaning with cleanshing and disinfectant agents • Sufficient amount of clean uniforms should be provided by the company to all employees and where ever necessary the employees should be equipped with hats/ Caps (Head covers), aprons, safety shoes, gloves, disposable gloves, masks etc. • Purified water should be provided for drinking and manufacturing purpose • Special areas should be allocated out of the production premises for the placement of rejected and waste material prior to disposal. • There should be a disposal plan for the rejected and waste material.

9. Raw material, Finished Goods & Scrap Stores Adequate space should be available with Receipt and Issues Department , Packaging & Stationary Section, Finished Godown & Scrap Store, and every thing should be placed in order as per requirement. • Receipt and Issue Department, Packaging & Stationary Section, Finished Godown and Scrap Store should be separately designed to minimize the cross contamination and filth. • There should be special place designated “Inspection area” where all the supplies will receive, inspected and after the clearance of Quality Control and Quality Assurance it will be shifted to its allocated place and if some material/ item is rejected a special place should also be allocated for such item(s) which are suppose to be return to the supplier. • Those raw materials which need special temperature should be placed in that area. • The whole building/ Machinery should be electrically conductive. The temperature meter and hygrometer should be placed where aver required. • Proper exhaust facility should be provided where required. Fire extinguisher plan should be displayed and the fire extinguishers should be placed accordingly.

10. Control of Machines, Equipment & Associated Utilities All Machines, Equipment and associated utilities which are related to the quality of the product should be controlled under a system, which ensures that:- • Suitable maintenance of Machines, Equipment and associated utilities. • Preventive Maintenance Schedules are made and records of maintenance are maintained, including breakdown maintenance as well. • Calibration intervals are defined on the basis of its usage, sophistication or information provided by its manufacturer. • The calibration of instruments is carried out at defined intervals and the reference master equipment’s standards are traceable according to the valid national or international standards

11. Competence, Awareness and Training • Personnel performing work affecting product quality should be competent on the basis of appropriate education, training, skills and experience. • There should be a system to determine the necessary competence for personnel performing work affecting product quality, provide training or take other actions to satisfy these needs, evaluate the effectiveness of the actions taken, ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and maintain appropriate records of education, training, skills and experience.

12. Procurement Protocols The Company should manage its purchases from the suppliers, which have the ability to meet the quality and quantity requirements. Therefore, the sources of supplies should be carefully evaluated and afterwards they will be included in the approved suppliers list. The periodic performance evaluation of the approved suppliers should be done to re-evaluate their performance. Purchasing Information All purchase requisitions must contain all relevant information. This information will be prepared by relevant Department. Prior to release, the purchase orders should be reviewed and approved against the description of products, technical details, specifications, quality, quantity, price and delivery schedules Verification of Purchased Products The purchased products should be verified for quantity and quality by Quality Assurance/Control Department or the user departments upon arrival. The non conforming products should not be accepted and will be returned to the supplier/vendor.

13. THE MODEL RAW MATERIAL STORE

14. THE MODEL FINISH GOODS STORE

15. Production & Control Records • To ensure the uniformity from batch to batch there should be a system to plan and develop the processes needed for product realization. Planning of product realization is consistent with the requirements of the other processes of the quality management system. • For planning & product realization, a company should determine the following: • Quality objectives, standards and requirements for the all products (Which include Product Name, Batch Size, specifies absolute amounts of specific potent ingredients and excipients, Quality Control tests & standard, Manufacturing protocol, Practical Yield, Packaging and Labeling standard & instructions); • The need to establish processes, documents, and provide resources specific to the product; • Required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;

16. Model Potentization Department (particularly for Homoeopathic medicines)

17. Production & Control RecordsContinued ….. • These records should be retained for at least 2 years after the batch distribution is completed or at least 1 year after the batch expiration date, which ever is longer. • To facilitate the quality planning, “Quality Plans” should be used which serves as frame work for the construction of the system. • To achieve the desired level of product quality, quality parameters and standards should be defined which will monitored and necessary changes can be made according to the requirements. The quality related jobs should be performed by the trained personnel and quality records should be maintained as an evidence of compliance with the system. • Process travel card provide evidence that the realization processes and resulting product meet requirements.

18. Work In-Progress Viscometer for testing the Viscosity of thick liquids (QC Lab) Quality Assurance during Process of Tablet Compression

19. Work In-ProgressContinued …… Cap rotating through auto driver in Classical Wing Blister machine in operation

20. Quality Plan – Mother Tinctures Material Issued from Raw material store (Properly labeled, wrapped & packed) Plant and Animal Substance Insoluble Mineral Substance Check Substance Check Animal Soluble mineral Substance Plant Fresh or Dried Material Dissolving of material into in-active Trituration Method Grinding/Cutting & Maceration Soaking of Material Filtration 1 Part crude + 9 part Lactose = 1X Trituration (Decimal System) Extraction 1 Part 1X + 9 Parts Lactose Filtration / Percolation Mother Tincture Centesimal Scale Decimal Scale 1 Part Ø + 99 Parts menstruum 1 Part Ø + 9 Parts menstruum Succussion Succussion 2X Potency 2C or 2 Potency 2X Tritutation Subsequent Potencies

21. Measurement, Analysis & Improvement There should be a system to plan, implement and monitoring, measurement analysis and improvement processes needed to demonstrate conformity of the product. Internal Audit To ensure the conformity and compliance of written quality assurance parameters and its implementation, periodic internal audits should be conducted by the qualified personnel who are independent of the activity to be audited.

22. Measurement, Analysis & ImprovementContinued …… Process • The measurement of process should be done by the production and recorded on the “Process Travel Cards”. This data demonstrates the ability of the processes to achieve the planned results. If the planned results are not achieved, corrective and preventive actions are taken to ensure the conformity of the process/product Product • Monitors and measures the characteristics of the products to verify that requirements specified by the customer are met. The inspection is carried out at incoming level for the raw materials, at in-process and final stages to ensure the conformance of the products. • Evidence of conformity should be maintained at the “Process Travel Cards” and relevant reports which indicate the authorized release of the product for the subsequent stage. • The product is not released for the next stage until the monitoring and measurement activities are completed or unless otherwise approved by the relevant authority or the customer..

23. Measurement, Analysis & ImprovementContinued …… Analysis of Data There should be a system to determines, collects and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data provides information relating to: • Customer satisfaction via customer feed back, • Conformity to product requirements by quality control tests, • Characteristics and trends of processes and products including opportunities for preventive action, and • Suppliers performance.

24. Measurement, Analysis & ImprovementContinued …… Continual Improvement Customer satisfaction is measured and corrective/preventive actions are taken for a consistent and continual process of improvement. The quality policy objectives, results of audit and corrective and preventive actions are also taken as a mean of Improvement tools. Corrective Action The corrective actions are taken to assure that management takes an eliminating step to rectify the non-conformities and to prevent their re-occurrence. Preventive Action To avoid the occurrence of potential non-conformities, the preventive actions are taken

25. THANKS