Industrial Environment of a Pharmaceutical Company - Case Study Example

Industrial Placement Report Introduction The pharmaceutical company the Company ) I work for, produces only drugs. The Company does not develop new products. Therefore it does not have Research & Development department, although it has a laboratory. The laboratory provides testing for quality at all the intermediate phases of the drug production and the final products: tablets and capsules. It also provides testing for sterility of the workplace. Quality assurance, that productions areas or processes are sterile and do not in themselves provide a possible contamination, is another important function in the pharmaceutical industry. The engineering department in the Company provides maintenance management and repairs on all equipment. It comprises of work orders, scheduling, service requirements, data collection, parts and inventory management, and forecasting of parts and inventory needs. When a piece of manufacturing equipment needs regular servicing, that task automatically appears on a list of work to be done, and a plant technician will perform the work, making a note in the system that it was done, by whom, and when. Engineering department is also recording all variations in production and quality and organizes the remedial actions. I work in the packaging department ( the Department.) In this report 1) I shall give my view, both, on the Department side and on the production (i.e. manufacturing) side of the Company. I will discuss three important elements of a successful operation of any pharmaceutical firm: Quality Assurance (QA), Safety procedures (SP) and, above all, Information Technology. As Information Technology (IT) and automation is involved in virtually every production and quality assurance (QA) process, I shall mention the IT role in individual processes as I will keep describing them further on in this report. 2. Production Lines and Packaging Department The Company produces only tablets and capsules. A high degree of automation exists in the production side of the Company. Milling and micronizing machines, which pulverize substances into extremely fine particles, are used to reduce bulk chemicals to the required size. These finished chemicals are combined and processed further in mixing machines. The mixed ingredients may then be mechanically capsulated, pressed into tablets. Our part of the ( packaging) Department works only with tablets, but the Company produces capsules as well. The workers in the Company fall into one of two occupational groups: Production workers who operate drug-producing equipment, inspect products, and install, maintain, and repair production equipment; and transportation and material moving workers who package and transport the drugs. This is the role of our Department. Generally, I can characterize the technology in our Department as being medium-automated. Since the Company has three tablet-producing, fully automated, lines, we are packaging three different types of tablets. For that, our part of the Department has three packaging lines, each consisting of one blister packing machine, one cartoner and an overwrapper. These three units are all connected into a series. The inputs into this three-machine series are: tablets, cartons and leaflets and at the end, as output, comes packaged product, already in cartons with proper labels attached. Then we further pack the cartons into outerboxes. 3. Good Manufacturing and Production Practices There are several major items that we see important in our work space: Generally, working conditions in pharmaceutical plants are better than those in most other manufacturing plants. In the Company, there is a stress on keeping equipment and work areas clean because of the danger of contamination. We work in air-conditioned, well lighted, and quiet place. Health and safety regulations ( to be discussed later in paragraph 6 ) concerning workers, checked by the engineering department and laboratory staff and enforced line and department managers, ensure that our Company workers are protected from over exposure to chemical, biological, physical hazards. Preventive maintenance of all drug-production, testing and IT equipment (automated machines, IT hardware, constantly-updated software and databases) is a must. In our Department, most workers are trained how to repair minor problems in-house and are actually motivated to do so. The actual preventive maintenance of complex equipment or the repair of such equipment is done by engineering department. Each department have their own system of recording of all issues occurred during the production shift. Engineering department is recording all variations in production and quality as "Unplanned Work Orders" or "Out Of Specification" results. All these deviations during production runs are detected and recorded (through IT or optical observation) and immediately investigated and corrected. Equipment validation is very important everyday issue in our workplace. All equipment which is used in my area ( of the Department ), such as: ERH testers, bench and floor scales, drum sealer machines, need to be validated. We are not allowed to use equipment which is not validated or when the validation date has expired. Testing of sterility of the workplace is another major task. Sterility testing is widely employed especially in pharmaceutical industry to provide complete assurance that productions areas or processes are sterile and do not in themselves provide a possible source of contamination. For example the process validation used to determine aseptic processing in the pharmaceutical industry is called the Media Fill Test. This test utilizes sterile culture media instead of actual product. In the Company, all testing for sterility of the workplace is performed by laboratory professionals. 4. Quality Assurance Effective and comprehensive Quality Assurance (QA) programs (based on the review processes) are developed to ensure producing and marketing safe, effective and quality drugs. Our laboratory ensures, that before the full quality-control testing and process monitoring is established in accordance with customer and product requirements, that the drug is safe and effective. We use an extensive range of analytical techniques and instrumentation to ensure the highest standards are maintained at all times in our premises. This is backed by a comprehensive Quality Assurance System and concise documentation at all stages of processing. To summarize: Quality assurance ( QA ) and Quality control ( QC ) and are vital in this industry. Quality control, together with quality assurance has to ensure constant reproducible characteristics of drugs. In the Company, the laboratory is, at the end, responsible for, both, QA and QC of not just the quality of the final products but also of the quality of the basic materials, and quality of all intermediary products between the beginning and the end of production lines and packaging department. As the laboratory has this over-all quality control mandate, it also has to keep the workplace sterile, so that the final product would not get contaminated during the production processes. In the Department, all people working in my area are trained on how to perform some basic quality tests (which do not need special laboratory equipment and knowledge) and, thus, are being responsible for some quality control in the area. Support functions include: A comprehensive quality assurance system Complete quality control analysis Modern well-equipped premises Extensive range of instrumentation Highly trained and qualified staff. General Example: Throughout the production process, inspectors, testers, sorters, samplers, and weighers ensure consistency and quality. For example, ampoule examiners inspect ampoules for discoloration, foreign particles, and flaws in the glass. Tablet testers inspect tablets for hardness, chipping, and weight to assure conformity with specifications. After the drug is prepared and inspected, it is bottled or otherwise packaged by packaging and filling machine operators and tenders. A strong focus of attention is directed to the study of blister packs. Typically, the traditional industry-wide evaluation method consists of making blister packs (which generally contain multiple blisters) with the size and packaging material specifications to be tested; however, a desiccant (usually silica gel or magnesium chloride) is placed inside the blister rather than the actual pharmaceutical product. The blisters are then placed in an environmental chamber at constant temperature and humidity conditions ( there are several combinations, but the most common one is 23C and 75%RH). The weight of the sample blister is then measured at certain intervals of time for 28 days. 5. Quality Control Quality control (QC) has to ensure constant reproducible characteristics of drugs. Standard analytical procedures for individual pharmaceutical compounds, active ingredients and auxiliary reagents comprise time-intensive sample preparation steps and require accurate determination of titer and blank values of solvents. Efficient and secure performance of the analysis is crucial in order to make it operator-independent, thereby ensuring the integrity of test results. The idea behind all of these individual analyses ( showing the quality assurance and/or control ) is simple: Each pharmaceutical product runs through various stages of the quality control process during production - from the laboratory analysis of the base materials and tests during each individual production stage right through to the final checks. These tests and checks, for example, verify that the active agent content and its release correspond precisely with the manufacturing specifications. Typically, in my Company all materials received from suppliers need to be sampled and tested before we can use them. Then, during the production process, we have to perform the required number of tests which we were trained to do and at the end, before a lot can be released, samples taken during production are send to the laboratory for final tests. Actual Example: We are performing checks on blisters, cartons and, for some of the lots, also tablet quality checks. During the on-line lot-checking by trained production technologists, we are checking blisters: Every 15 minutes for emboss, print, perforation, sealing pattern, pockets alignment, and Every hour we provide a MDT blister packs seal test (blisters are put into the methylene blue dye under the pressure to see whether they are sealed correctly and whether the lidding foil is not damaged; compare with General Example in paragraph 4). For some products (tablets), an ERH (Equilibrium Relative Humidity) test see the General Example humidity in paragraph 4 is done every 2 hours and, also, print camera test are performed. As we deal with tablets, different type of samples and quantities are taken for different tablets (according to test specifications): For the tablets AD-4833, we take only required number of packed blisters at the start of the lot. For AG1749, at the start of lot, the production executive has to count which outer boxes need to be checked for acceptable quality level (AQL) during the run. That is every 1/5th of the lot target. During AQL we are checking blisters quality, print quality and tablets as well. For AD-MET, the same portion ( i.e. 1/5th of the lot required amount ) of cartons are checked. But, just as in case of AG1749, we do not perform tests for tablets quality. This is done in the laboratory where the samples were sent. To summarize: Following the quality assurance (QA), there are different levels of quality control (QC) in the Company. The actual final tests of products quality are all performed in the laboratory because they required special equipment and specialized knowledge. All the basic quality control, that can be done without specific laboratory equipment, such as: MDT and ERH tests for blisters quality, labels, and even some quality tests at the beginning stage, are performed at the Department level. The employees at the Departmental levels are encouraged to provide some basic quality control and take initiative in identifying process or sub-component faults. It could be seen as a cultural change for the organization which is known as Total Quality Control (TQM). This generally leads to the higher level of QA and QC as managers have to learn to support, encourage and listen to line workers who usually have much better overview of the problems in the workplace. 6. Health and Safety This issue has a direct tie to the quality control and quality assurance (discussed in paragraphs 4 and 5). Two factors enforce a high degree of quality control, assurance and monitoring in the pharmaceutical industry: (a) complying with health and safety regulations of workers our Company protects workers from over exposure to chemical, biological, physical hazards and physically demanding tasks in the work place and (b) minimizing hazards to the workplace when dealing with dangerous chemicals and to the customers (by producing non-standard products). In order to guarantee safety and quality and reducing risk of product recall in our Company, these policies are in place: Monitoring, testing and inspection are carried out on materials and products at numerous stages. Raw materials and goods may be allocated to a quarantine warehouse where special conditions are maintained, code dates (for re-test and expiration) on products are monitored, and receipt and release can be authorized. Programs in place to prevent or mitigate catastrophic releases of chemicals. Safety information relating to hazardous materials - including pharmaceutical compounds and pharmaceutical intermediate materials - shall be available to educate, train, and protect workers from hazards. 7. Information Technology The pharmaceutical industry has, in general, a whole range of critical operations. In the case of our Company, these are: Manufacturing Distribution and Sales ( customer relationship management) Under Manufacturing there are two sub-divisions: production planning, and Quality control (QC), including all the safety issues in the Company discussed in paragraph 6. Under Distribution comes the warehouse management, which involves my Department (i.e. packaging, labelling, visual quality control, etc.) while Sales involve all the CompanyCustomers relations. As my work in the Department does not involve either direct sale or product planning, I will describe the IT functions in the QC of the Company automated production lines and in the distribution. In the Company manufacturing process automation system applies on each production line. These systems are designed such that software packages incorporate data related to the manufacturing process. As the production ( manufacturing ) processes are being performed, workers take manual records and data are manually entered back to the application to complete the planning/resource function. The information technology (IT) system provides electronically and automatically report, track and resolves deviations. As we build control chart into it to detect causes of variation that are easy to remove, it not only provides operational efficiency in production but, above all, quality control and compliancy with the recipes. Automation in our Department is characterized by the physical base of drugs, its packaging and its final form. In my case, working with solids ( as a physical base ), powders have to be formulated to its final dosage through process steps such as weighing, blending, granulating, tableting and, finally, making blister packs. These process steps are done with automatic machines equipped with human machine interfaces to aid in the operations and production lines. Specifically, in my Department we are using IT to check in and out material, consumption, reconciliation and final reports etc. All the test are recorded in the PI (packaging instruction ) which need to be followed during each production lot. In fact, complete information about: all performed tests, full instruction step by step how to start the lot, do all set-up and start-up tests, in-process tests, how to perform accepted quality level ( AQL ), run the lot etc. are entered in the PI system, by people working in the area. As part of production quality control, automated inspection machines are also employed but usually at the end of the production line to ensure quality of the formulation and final packaging by weight, level, vision, etc. Then the tested products will end up in final packaging for shipment. 8. Conclusion This report wants to show, how I see the industrial environment of a pharmaceutical company from the point of a packaging department worker that has been with the Company for three and a half year. Although my Department is almost at the end of the whole production chain of the Company, there are many, if not all, departments of the Company that are connected with a single goal to reach. The goal is to produce drugs, in my case, tablets, such that every batch coming off a production line could flawlessly reproduce the original design and that the active drug content and its release correspond precisely with the manufacturing recipe. In the report I was trying to focus on the other production sectors that actually make the products that we package and further distribute. The major connecting link is the quality control (QC), usually managed by the IT software. It does not matter whether QC is automatic (as in the case of production lines) or half-automatic and half-visual (and/or manual) as in our Department. As long as every employee does his best to report and correct the deviations from the norm as soon as possible, our Company will prosper. 9. Notes 1) Lane, D. "Industrial Placement Report." Read More