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HR and Administration HR Human resource management (HRM) is the set of organizational activities directed at attracting, developing and maintaining an effective workforce. The people working in the Human Resources department are contrasted with the responsibilities involved with finance and personnel of an organization. This department is a critical component of employee well-being in any business. The objective of this department is to maximize the return on investment from the organizations human capital and minimize financial risk.
The HR department is entrusted with the following responsibilities: 1. Recruitment selection 2. Training and development 3. Performance management 4. Motivation The motto of the HR department is: “Majority is accepted but minority should not be neglected” 1. Recruitment and selection Recruitment is the process of attracting individuals to apply for jobs that are open. This process is involved in selecting and hiring highly skilled and diverse talent into business functions. In Healthcare Pharmaceuticals Ltd. , recruitment process follows a certain format in a series of steps:
An employment application or requisition form is used containing details such as position, qualification required as well as job description. The form may also contain details regarding the fact if whether it is for a new position or a replacement. After the data is accepted then a certain time period is allotted for searching. It is usually one and a half months for experienced personnel and two weeks for fresh graduates. Advertisement is then done on newspaper or in websites; however both media have their own benefits and drawbacks. After the deadline, a sorting is done where 15 to 20 candidates are picked.
Out of them, 5 top 7 candidates are chosen for the preliminary interview. The interview board consists usually of the head of the department in which the position is required, a member of the HR department and the plant manager. Each of them assessment forms and check the educational qualifications as well as behavioral characteristics of each of the candidates. After the preliminary interview the board selects the best two and calls them for a second interview. The candidate whose preferences match with that of the company gets the job. After recruitment, orientation of the newcomer is done.
The management is informed of the addition and the newcomer is introduced in every department and notified of all the interactions necessary to carry out the job. Finally the newcomer is taken to his/her own department and is informed of his/her work and related SOPs. The SOP or Standard Operating Procedure is an essential part of a pharmaceutical company and is integrated into the backbone of every system. It is a set of instructions having the force of directive, covering those features of operations that lend themselves to a definite or standardized procedure without loss of effectiveness.
SOPs can be effective catalyst that can drive performance improvement and improve organizational results. Every good quality system is based on its SOPs. The general format of a SOP consists of the following details: 1. Purpose 2. Scope 3. Archival period 4. Safety 5. System owner 6. System description 7. Instruction 8. Responsibility 9. Procedure 10. Keyword 2. Training and Development Training refers to teaching operational or technical employees how to do the job for which they were hired. Development refers to teaching managers and professionals the skills needed for both present and future jobs.
One of the best ways to improve a company is to raise the capability of its people and there is no better means of achieving this than through training and development. In Healthcare Pharmaceuticals Ltd. , and yearly evaluation is carried out to identify areas or personnel in need of training. In 90% of cases internal or in-house training satisfies the need. In certain cases external training is given. Other than these training, there is always a compulsory training that is carried out at the start of very year regarding job description, GMP guidelines, security etc. for every department.
At the end of the training, an assessment is done to see the success of the training. If the percentage of the results of the evaluation turns out to be below 70 then the training is subjected to change. 3. Performance Management Performance Management is actually a formal assessment of how well an employee is doing his or her job. Usually assignments and trainings are given throughout the year and an evaluation is done at the end. Job performance as well as personal qualities such as sincerity, attendance and co-operation etc is monitored. In fact grades are given as according to performance
At Healthcare Pharmaceuticals Ltd, every year, subordinates and their supervisors are given a week to show achievements and flaws of the subordinate in a discussion and an appraisal from is given They both bargain for the grade, each justifying their sides. The after an agreement is reached a recommendation is given. Three recommendations qualify personnel for a promotion and then there are increments and performance bonuses. Afterwards, the subordinate prepares the objectives for next year and gets it checked by his/her supervisor. A summary sheet is then made and signed by the Managing Director (MD).
Furthermore, an individual motivational letter is sent to each employee. 4. Motivation Motivation involves enabling employees to work better by satisfying their need and assuring them of an affable working environment. Motivational activities include external training, bonuses, holidays, picnics as well as encouragement and co-operation among personnel. Administration The administrative department works along with the HR department providing supporting functions for an effective working environment. The administrative department consists of three major units: 1. Corporate or Head Office 2.
Industrial Plant 3. Distribution Company 1. Corporate or Head Office Healthcare Pharmaceuticals Ltd Head Office is located at elephant road in Wagers Complex. The Head Office deals with the following responsibilities: Overall management Export to other countries For export, the rules of the country in which the export is made is followed. The representatives of that company will perform a primary and then a secondary audit. 2. Industrial Plant The industrial plant is in Rajendrapur and is located around 50 miles away from Dhaka, towards Mymensingh. The general administration here deals with: I. Security Three layer system II. Entertainment and canteen -Daily meals and occasional feasts III. Cleanliness and Beautification -Keeping a neat and tidy environment. 3. Distribution Company The distribution company sends requisition requests to the head office for materials and enables processing It is also involved with medical information officers and sales of products (sample medicines given to doctors). Material management Material management Material management oversees the warehouse, incoming raw materials, and shipment of products and ensures the integrity of all the necessary documentation and materials.
Warehouse is an essential department of a pharmaceutical industry. Here, all received raw materials, packaging materials and finished products are received, stored as per specific conditions and then distributed. A warehouse stores the following materials: A. Raw materials • Active pharmaceutical ingredients • Excipients B. Packaging materials • Primary packaging material • Secondary packaging material C. Finished products Functions of warehouse 1. Receiving of all materials (raw materials and packaging) 2. Storage of raw materials, finished products and packaging materials 3. Storage of rejected or returned products before disposal . Maintain stock of inventory (finished products, raw materials and packaging materials) 5. Follow up on VAT activities. There are two storage rooms in the warehouse: 1. One is for active ingredients and excipients 2. The other is for packaging materials Areas in a warehouse 1. Receiving area 2. Quarantine area 3. Sampled area 4. Approved area 5. Area for raw materials 6. Area for finished products 7. Narcotic room 8. Cold room 9. Rejected room 10. Returned room 11. Cool room 12. Printed material room 13. Sampling area 14. Product dispatch and raw materials receiving room 1. Receiving area
This is the area in which the materials are received and weighed from delivery vehicles. They are also cleaned and checked as according to vendor list 2. Quarantine area This is the area where the materials are first kept after being received prior to sampling by Quality Control personnel. The products in this area are tagged with a yellow colored “Quarantine” label. A “Quarantine” label consist of details like name of material, code number, batch number, QC reference number, container number, quantity and status. 3. Sampled area This is the area where the material from which the Quality Control personnel has taken samples is kept.
The materials in this area are tagged with an orange colored “Sampled” label. A “Sampled” label consists of details like name of material, code number, consignment number, sampled bag number, date and name of the person who sampled it. 4. Approved area This is the area where the materials from which the samples taken by the Quality Control personnel have been tested and accepted. The materials in this area are tagged with a green colored label “Approved”. An approved label consists of details like name of material, code number, batch number, and quantity, assay and retest date. 5. Rejected room
This is the area where the materials from which the samples tested by Quality Control personnel have been rejected. Materials are tagged with a red colored “Rejected” label. 6. Area for raw materials After being approved, the active ingredients are kept in a separate e area as well as excipients 7. Area for finished products Products that have been manufactured and packaged are sent back to the warehouse from the production and kept in this area 8. Narcotic room This is a special room where controlled drugs like narcotics are kept. Government officials routinely check activities involving these materials. 9. Printed material room
Here all leaflets or materials related to drug literature are kept. 10. Returned room This is the area where the finished products that may have been damaged during transport or mishandling are kept. 11. Cold room In this area, sensitive and thermolabile substances such as flavors or pellets of sensitive ingredients are kept. The temperature in this area sis kept within 8 to 15°C. 12. Cool room In this area, materials like vitamins, hard gelatin capsule shells and enteric coated pellets of sensitive drugs are kept. The temperature in this area is kept with 15 to 25°C and is also called CRT or Controlled Room Temperature. 13.
Sampling area This area is mainly for Quality Control personnel. Here a Quality Control officer takes samples from the materials that are quarantined in the warehouse. This is done in a sampling booth. After sampling, the “Sampled” label is attached to the container of the materials 14. Product dispatch and raw material receiving room In this area there are two separate hatches, one hatch allows the dispatch of finished products from production are to the warehouse and the other hatch allows raw materials to be received by the production area from the warehouse as per requisition following the FIFO rule (First In First Out).
Helmets are worn in the store rooms as a safety measure. Flow chart of Material management process Materials received Approved vendor list is checked Invoice and VAT challan is checked Materials are cleaned outside store room Received in receiving area Certificate of analysis is checked along with other details Registered in receiving entry Goods Received Note (GRN) made QC receives GRN Materials kept in Quarantine are (Tagged yellow) Sampling and tests are done by QC (Orange tagged done) After results materials go to approved area (Green tag) Goes to released area Production department gives requisition Given by FIFO rule VAT Challan
VAT or Value Added Tax is a governmental tax, imposed on all goods. It is usually 15% of the cost of the goods. When materials are received, an invoice or VAT Challan is checked. Furthermore, for finished goods, credit is taken from the Bangladesh Bank on advanced payment (included with VAT) and then after sales, this amount is cut off from the sales month or debit is issued. The balance of a company should never be negative. It should always be positive. Some of the VAT Challan formats are: Mushok 1: Price approval of materials from Drug Administration Mushok 11: VAT approval from VAT authority Mushok 16: Purchase register
Mushok 17: Sales and production register Mushok 18: Account current register Production Production Although all departments are essential in an industry, the production department may be regarded as the core of a pharmaceutical industry. It is involved with the manufacturing of medicines and packaging them At the current moment Healthcare Pharmaceutical Ltd. is associated with the manufacture of oral solid dosage forms like tablets and hard gelatin capsules. However, it also sells vaccines under toll manufacture by Popular Pharmaceuticals and manufactures effervescent tablets under toll manufacture for Novartis Pharmaceuticals.
The different areas of a production department are: A. Manufacturing area 1. Dispensing unit 2. Granulation unit 3. Compression unit 4. Coating unit 5. Encapsulation unit B. Packaging area 1. Primary packaging unit 2. Secondary packaging unit Other areas are: 1. Equipment wash unit 2. WIP (for granules and another for tablets and capsule) 3. Cleansing equipment and assembly 4. Technical area 5. Pharma workshop 6. Store 7. Coding and folding 8. Product dispatch and raw materials receiving area 9. Weighed material area 10. Un-weighed material area Stages of production The manufacturing process of a tablet follows the following steps: . Dispensing 2. Granulation 3. Compression 4. Coating 5. Packaging 1. Dispensing Dispensing is the process in which raw materials are received from the warehouse and certain amount is taken from each material as required to make a batch of tablets. Dispensing is done under controlled conditions in a dispensing batch. Principe of dispensing 1. Only one chemical is taken at a time to avoid cross-contamination 2. Differential air pressure is used 3. Active ingredient is dispensed last. Precautions taken during dispensing 1. Product name according to BMR (Batch Manufacturing Record) is noted. 2.
Product code number is noted 3. Retest date and expiry date are noted 4. Factor for potency adjustment of active ingredient is calculated and noted 5. QC reference number and sample number are noted 6. It is also noted whether assay has been carried out or not. Process of dispensing 1. Dispensing starts with receiving of starting material. The following details are noticed: • Cleanliness of containers • No breakage • No material except this relevant to that particular batch is presnt • Correct material of sufficient amount with approved label from QC is checked. 2. Prior to dispensing, the following details are noted: Removal of all extraneous material and equipment from the room • Cleanliness of room and equipment in which dispensing will take place • Calibration of balances • Room conditions like temperature (18-27°C), Humidity (50—65% RH), and Air Pressure (5-25 Pa) are maintained. • For moisture sensitive materials, more strict conditions are followed. 3. Before dispensing, the raw materials are received form the warehouse, and kept in a room labeled “Un-weighed material”. After dispensing, the raw materials are kept in a room labeled “Weighed material”. 4. During dispensing (carried out in laminar air flow hood), 2. % overage of all materials are included. Furthermore, potency adjustment is made with suitable excipients, usually it is the diluents. 5. Then, coating material is dispensed and 60% extra amount is taken (to compensate for loss during coating) 6. During dispensing a “Dispensing” label is attached to the containers. After dispensing a tag called “Under Issue Label” is attached to the container with the remaining raw material and given back to the warehouse. This label consists of details of the initial amount, final amount and the amount of raw material taken for production.
All these activities are carried out under the supervision of a pharmacist Machines used in dispensing: • Air Tech Laminar Air Flow Hood Country of origin: USA • Avery Berkel Floor Balance Model: H302/L115 Country of origin: England Capacity: 60 kg • Sartorious Precision Balance Model: BP 2100S Country of origin: Germany Capacity: 1. 7 kg 2. Granulation Granulation is the process in which solid particles are made to adhere to form larger particles or aggregates called granules. Granulation is the first step in the manufacturing of tablet. Importance of granulation
Granulation improves flow property of raw materials enabling efficient compression to form tablets. Types of granulation 1. Dry granulation 2. Wet granulation Dry granulation is usually carried out for moisture sensitive materials Flow chart of Dry granulation Weighing of raw materials Active ingredient + Diluent Sieving through 20 mesh SS screen Sieving of disintegrant and mixing with active ingredient and diluents (Active Substance Mixture) Lubricant mixture is sieved and mixed with active substance mixture Blending is done Submit sample to QC with Test Request Ready for Compression Parameters to be noted in granulation . Energy used (kW) 2. Speed of rotation (rpm) 3. Blending time Tests that are done on granules by IPC and QC are LOD, appearance, color identification and determination of substance content. Wet granulation Wet granulation is done for products that are not moistures sensitive. This process is a bit complex but produces elegant tablets that fit all test parameters. Flow chart of Wet granulation Dispensing of raw materials Dry mixing of ingredients (except binder) in granulator Addition of binder paste Mixing at low speed for a few minutes Mixing at high speed for a few minutes Unload and mill in cone mill
According to LOD, dry granules in fluid bed dryer Check LOD Mill again Blend in container blender Send sample to QC Granules are ready for compression Machines used in granulation • Servolift Container Blender Country of origin: Germany Capacity: 1000 kg • Collete Granular Mixer Country of origin: Germany Capacity: 300 kg • Fluidized bed dryer Country of origin: Germany Capacity: 120 kg • Cone Mill (VMT 200) Country of origin: Switzerland Capacity: 250 kg • Drum Blender Country of origin: Germany Capacity: 60 kg 3. Compression Compression means a reduction in the bulk volume of the material as a result of displacement of the gaseous phase.
When granules are made within the tablet manufacturing procedure, there are many interparticulate spaces or voids within them. Compression allows the displacement of such voids causing the granules to form a compact tablet using mechanical forces. Process of compression 1. Before compression, cleanliness of room and equipment are checked as well as room conditions 2. Initially, a small amount of granules are added to produce a certain number of tablets to check the following factors: • To ensure if machine is working properly and all the punches are fitted well To check if the tablets produced fits all the parameters 3. The compression machines used are generally rotary tablet presses meaning that the upper punches rotate and pressure is applied over them to compress the granules within the die above the lower punch to form tablets. 4. Granules are fed through the hopper and a fill-o-meter move granulation into the dies which determine the size of the tablet 5. The punches are either round or oblonged shape and are of the Euro D type. These compress the granules within the die. 6. Cam track helps in guiding the movement of the punches. 7.
Before the main compression, a pre- pressure roller is used to provide a pressure that takes out the air slowly out of the granules, preventing the granules to spread out. 8. During the compression process, an escaper removes excess unused granules which can then be recycled. 9. After the tablets are produced, they are passed through the De-duster machine to remove dust from them. 10. All the functions of the compression machine can be adjusted from the data control board. 11. Usually for a commercial batch, hardness, thickness and weight variation of the tablets are checked every half an hour 2. Furthermore a certain number of tablets are sent to the IPC and QC for tests. Parameters to be noted during compression 1. Pre pressure 2. Main pressure 3. RPM or Rotation Per Minute or disk speed 4. EFM or Ejection Force Monitor 5. Penetration speed 6. Lower punch position 7. Filling depth 8. AWC or Automatic Weight Control Problems that occur during compression 1. Capping and lamination 2. Picking and sticking 3. Weight variation 4. Hardness variation Flow chart of compression Addition of granules to hopper Adjustment of parameters Checking of tablets formed by IPC De-dusting of tablets
Sending samples to QC Store in WIP (tablets and capsules) or release for coating Machines used in compression • Sejong MRC 30N Country of origin: South Korea Capacity: 1, 80,000 tablets per hr • Fette P2100 Country of origin: Germany Capacity: 1, 04000 tablets per hr 4. Coating Tablet coating is the application of a coating material to the exterior of a tablet with the intention of conferring benefits and properties to the dosage form over the uncoated variety. Purpose of tablet coating 1. To improve the elegance of the product and for easy identification 2. To mask unpleasant taste and odor 3.
To protect from environmental conditions 4. To modify drug release characteristics Types of tablet coating Coating Sugar coatingFilm coatingEnteric coating Aqueous coating Non-aqueous coating In Healthcare Pharmaceuticals Ltd. film coating and enteric coating are done. Furthermore, only aqueous solvent is used in all coating processes, even for moisture sensitive products like Ranitidine with success. The coating materials used in all the processes is various forms of Opadry from Colorcon. Flow chart of coating process Coating solution is made (85% water and 15% material) Solution made in mixer
Added in spraying valve Solution is sprayed on tablets through nozzles while tablets are rotated Air is blown through perforate dribs of drum. Steps of coating process 1. Pre-heating 2. Spraying 3. Drying 4. Cooling Parameters of coating 1. Drum speed 2. Volume of air supply 3. Air supply temperature 4. Air exhaust temperature 5. Atomizing air pressure or inlet air pressure 6. Total application solution 7. Distance of nozzle to tablet bed Problems of coating 1. Sticking and picking 2. Roughness 3. Orange peel effects 4. Blistering 5. Mottling Machines used in coating • Driacoater 1200 Country of origin: Germany
Capacity: 120 kg • Silverson Mixer Country of origin: England Capacity: 25 kg 5. Packaging Packaging is an economical means of providing presentation, protection, identification, information, convenience and compliance for a product during storage, transport, display and use until the product is used. After tablet compression and coating (if required), the tablets are packed in blister packs or plastic containers which are then enclosed in inner cartons. Types of packaging material There are two types of packaing material 1. Primary packaging material These packages are in direct contact with the medicine e. g. lass bottle, plastic container, blister foil, cap/closure etc. 2. Secondary packaging material These are packages which contain the medicines enclosed in primary packaging materials. e. g. inner carton, package insert, shipper carton, shipper carton liner Certain tablets are packed in bottles or plastic containers while others are packed in blisters in Healthcare Pharmaceuticals Ltd. Primary packaging rooms A) Plastic bottle filling Tablets fed by hopper Vibrated onto channel guide Photoelectric sensor in channel guide detects number of tablets entering bottle Only one funnel at a time delivers tablets in container
Manual filling of padding and closing of the container Parameters 1. Number of tablets set in channel sensor 2. Batch totaliser 3. Speed of vibration Machines used in packaging • Tablet counting and filling machine C. E. King TB4 Country of origin: England Capacity: 2000 bottles per hour B) Blister packaging Roll of PVC or Alu bottom foil is taken within machine Pockets are formed by forming plate using air pressure (Heat not required for Alu foil) Tablets are fed into pockets from feeding drum Another roll of Alu foil is laid over the tablet filled side The two layers are sealed Perforation occurs for uniform division of tablets
Cooling occurs Packs are then cut according to size Packs are then moved to secondary packaging room Temperature settings a) For bottom PVC layer Pre heater Sealing Slitter 137°C182°C28°C b) For Alu bottom foil Pre heaterSealing Slitter Not required215°C100°C Parameters to be noted 1. Temperature of pre heater, sealing and slitter 2. Air pressure 3. Tablet feeding rate 4. Number of tablets per pocket Problems in blister packaging 1. Empty filling of pockets or excess filling of pockets 2. Printing problems 3. Sealing problems 4. Picking problem 5. Slitting problems 6.
Pre heating problems, related to malleability of packaging material Machines used in blister packaging • Horn + Noack Blister Packaging Machine Country of origin: Germany Capacity: • Hoonga Blister Packaging Machine Country or origin: South Korea Capacity: Quality Assurance Quality Assurance People working in quality roles are responsible for developing and implementing systems to ensure that medicines are manufactured to the high quality expected and that the final products satisfy the quality aspects of the regulatory requirements relating to them. Quality assurance also consists of Quality Control (QC) and In-Process Control (IPC)
Quality compliance Quality assurance (QA) personnel ensure that there is a quality system for design, manufacture, packaging, labeling and storage of medicines. Certain changes whether planned or un-planned during production as well as other aspects of the product already released are handled by the QA personnel. Some cases are: • Change Control When a certain change is planned from an established system, a document known as “Change Control” is used. e. g. Change of a packaging size of an existing product • Deviation This form is used when an un-planned event occurs in the system and action has to be taken. e. g.
Breakdown of a machine during production. • Out of specification (OOS) This form is used when any material fails to meet the specifications as stated in a quality control test for that material even after several attempts. e. g. failure to meet potency specification for any product in a QC test. • Product complaint This form is used when a complain about a product is received, after it has been released. A thorough investigation is carried out, if there is any problem with the product then the company offers a sincere apology, however if there is an problem with the complaint issuer then that problem is informed to them.
Quality control Quality control ensures that every medicine is of the highest standard possible. It includes sampling, setting specifications for and testing raw materials, intermediates, finished products and packaging Responsibilities of Quality Control Department 1. Carries out sampling and tests of raw materials 2. Carries out tests for intermediates 3. Carries out tests for finished products 4. Carries out test for packaging 5. Carries out microbiological tests 6. Monitors cleanliness of equipment and room Flowchart of Quality Control Functions: i. For Warehouse Raw material received by warehouse
Warehouse sends GRN to QC QC takes samples initially giving quarantine tag, then sampled tag Composite sample produce Subjects samples to method of analysis If all tests comply, then gives approved tag GRN sent back to warehouse ii. For Production Department Production uses raw materials to produce intermediates (granules) Sends request for test to QC and some tests are also done by IPC After tests, intermediate released for compression After compression and coating (if required) Tests done by QC and IPC on finished products and packaging Tests done by QC department 1. High performance liquid chromatography (HPLC) . IR spectrophotometry 3. UV spectrophotometry 4. Atomic absorption spectroscopy 5. Measurement of optical rotation 6. Refractive index measurement 7. Viscosity check 8. Dissolution testing 9. Disintegration test 10. Loss On Drying (LOD) 11. Stability test 12. Karl Fischer titration 13. Microbiological tests IPC IPC or In-Process Control is a part of QC but is present in the production department as it has to perform tests constantly along with the manufacturing process. Tests done by IPC 1. Disintegration 2. Loss on Drying (LOD) 3. Hardness 4. Thickness 5. Friability 6. Weight check Machines used in QC department Melting Point Instrument Mettler Toledo USA • Polarimeter Bellingham Stanley Ltd. UK • Fourier Transform IR Spectrophotometer-8400 Shimadzu Japan • IR Moisture Balance Sartorious Germany • Vibratory sieve shaker Fritsch Laboratories Germany • Milli-Q HLPC grade water system Millipore USA • Ultra Sonic Bath Power Sonic 510 Germany • Disintegration machine • Dissolution machine Erweka Germany • HPLC Waters Usa • Atomic absorption spectrophotometer-6800 Shimadzu Japan • Muffle furnace Naber Switzerland • Stability test chamber (40°C and 75% RH) Lunaire USA • UV spectrophotometer Shimadzu Japan • Autotitrator Mettler Toledo
UK • Centrifugation machine • Refractometer Bellingham Stanley Ltd. UK • DV-I +Viscometer Brookefield engineering USA Machines used in microbiology laboratory • Pass box Air tech • Autoclave Astell England • Laminar Air bench Air tech • Dry oven Heraeus Geneva • Incubators -Salvis incubator (30-35°C) -Memmert incubator (20-25°C) • Colony counter Stuart scientific • Water bath GFL • Microscope • Refreigerator Caravel • Conductivity meter 4320 Jenway • Electronic Balance Sartorious Germany Machines used in IPC • Disintegration machine • Friabilator tester • Hardness tester • Moisture balance Product development
Product development department (PD) This department is responsible for the development and validation of any new product of a company. This department also targets at the modification of existing products and paves ways for increasing sales of a company, hence playing a vital role in the pharmaceutical industry. Responsibilities of PD 1. Launching of a new product 2. Troubleshooting of an existing product 3. Development or modification of an existing product 4. By improving quality 5. By reducing cost 6. To develop analytical methods Process of launching new product 1. Marketing gives proposal for launching new product . The proposal is reviewed and accepted by the PD department 3. Recipe is made and submitted to Drug Administration 4. Sample for approval is sent to PD by supply chain 5. Sample is analyzed and if it complies then PD sends requisition to supply chain 6. Supply chain sends sample which is again analyzed 7. Lab batch is prepared using recipe and BMR developed by PD 8. Samples from Lab batch are analyzed 9. Analytical method is validated 10. Stability of product is checked 11. (Real time and accelerated stability tests are done) 12. While stability test are being done, the packaging material dimensions are set by PD 3. Design is set by Marketing department but the technical details are fixed by PD, QC and Production department 14. Later machine proofing is done and packaging material is finalized. 15. If the stability tests comply then supply chain and marketing are informed. 16. Marketing arranged for procurement of raw material. 17. An annexure is sent to Drug Administration with 6 months of stability data 18. DAR number is given by Drug Administration 19. Samples, analytical method, working standards etc are submitted to Drug Administration. 20. After raw materials arrive, analysis is carried out 21. validation batches are produced 22. These are then analyzed using samples 23. If the samples comply with test then commercial batch is started and product is announced to be launched. 24. PD department keeps stability samples even after product is released for further analysis 25. New BMR or second version is made by PD department and given to QC department and Production department and reviewed. 26. These are then accepted by the Plant Manager and QC manager. Machines used in PD laboratory • Disintegration machine Sotax DT3 • Tablet hardness tester China • Friabilator tester • Planetary mixer GMP 115
Gansons Engineering Ltd. India • Tablet coating machine Gansons India • Newtronic Walk-in Humidity Chamber • Fluid bed dryer Gansons India • Dry Oven Heraeus AG China • Adventurer electronic balance Ohaus USA • Drum mixer Gansons India • Tablet compression machine Kambert • Stirrer Rotavapor EL 130 Buchi Laboratories Switzerland. Engineering Engineering The engineering department ensures proper environment and Machines for production and QC department. Proper waste disposal, production of different grades of water, HVAC system, equipment maintenance and many more activities are handled by the Engineering department.
Responsibilities of Engineering 1) To provide continuous maintenance – Breakdown maintenance. – Preventive or routine maintenance. 2) To maintain and operate system services. e. g. – Chiller. – AHV. – Purified water system. – Qualification of equipment as done by engineering 1) Design qualification. 2) Installation qualification 3) Operational qualification 4) Performance qualification (done by production) Engineering also does validation for machine: 1) Prospective validation. 2) Concurrent validation. 3) Retrospective validation. Engineering department also carries out calibration of Machines
Production condition 1) Power from REB with a consumption of more than 1 MW. Generator – 638 kVA For uninterrupted processes like coating a 69 kVA generator is used HPLC requires 6 kVA UPS. 2) Chiller 3 chillers – 85 tonnes Used in AHU 3) Compressed Air 4) Hot water generator. 5) Boiler. 6) AHU 8 AHU units are present 7) Wet De – duster. 8) Dehumidifier. 9) HVAC system Water purifying plant. Water passes through reverse osmosis membrane and is then treated with ozone and finally with UV. It flows in a loop system and has a capacity of 8L/min.
Both Potable water and Purified water are produced for use in Healthcare Pharmaceuticals Ltd. ETP ETP of Effluent treatment plant disposes of all waster material. There are two types of drains: i) Surface drain (for rain water) ii) Underground drain (for waste water) This waste water is taken to equalize tank where it pH is maintained at an approximately 7, it is then passed through biological tower and then to a settling tank where sedimentation occurs and the clear water above is removed to a pond and its cleanliness is observed by addition of fish to it and observation of plant life around it.