Full transcript of “industrial Pharmacy Assignment”. Click a timestamp to open the video at that moment. Need another video? Use the YouTube transcript generator.
0:07 Over the last 50 years or so, there's been a massive improvement in human health. Life expectancy has increased virtually everywhere. A tremendous increase in the number of drugs, vaccines, and other medicines produced for human use has been a major reason for the advancements. At some point in our lives, we all need medicines of some shape or form. In general, all medicines we have access to have been carefully and rigorously tested to ensure their safety and efficacy. Yet, in addition to ensuring that all medicines are both safe and effective, it is essential to protect human health by ensuring that the products we are taking or administering are actually what they are supposed to be. If this is
0:54 not done, medicines may kill rather than cure. Ensuring that a drug or vaccine is manufactured properly so that it's safe and reliable and in the correct formulation helps to minimize the risk to our well-being, including some risks that cannot be covered in the testing and registration processes and procedures. We need to be assured that quality and reliability at all stages in the production process is of acceptable and reliable standard. If it is not, our health and maybe our lives are at risk. Good manufacturing practice is the name given to a fundamental component of an overall interdependent process of quality management. A process which must be
1:40 applied to any pharmaceutical product that is used to improve or safeguard human health. GMP is that part of quality assurance which ensures that the products are consistently produced and controlled to the standards of the quality appropriate to their intended use and as required by the marketing or licensing authorities. The film sequences you are about to see are a combination of GMP compliant and GMP non-compliance situations. The GMP compliance scenes were filmed at the Central Pharmaceutical Company number 7 in Kowan in Southwest Vietnam. In the GMP non-compliance scenes, the
2:26 persons and the company are all fictional, but all the manufacturing procedures did occur in one company or another at different times. [Music] This is Susan, age 7 and a half. Her dreams and plans reach beyond time and space to worlds clearly visible only to her. If things were equal, odds are she would find her way. But things are not. Susan has nephrosis. Her physician has started her on a
3:13 modification of hydrocortisone. We will call this fictitious drug steroid 47. Steroid 47 is a life sustaining drug. [Music] I'm not in. You never heard of me until we get that extra hormone order out of here. >> This scene is neither typical nor new to industry-wide experience. A sudden increase in orders has been received. The hormone steroid 47 is in accelerated demand and there are deadlines.
3:59 >> Well, tell them we'll speed up production all we can. Tom, I've toured before. All the equipment is committed. >> 3:00 p.m. tomorrow. That's the word from the front office. No matter what. No matter what. Of course, he doesn't mean that literally. Everyone knows that. Well, let's say almost everyone. This is the lab where raw material for steroid 47 is first examined for identification and assay. >> How's it going? >> Fine. Identification test checks out >> and the assay. >> It takes time. We haven't finished that yet. >> Well, then forget about it. There won't be any time. >> What? No assay? >> It's too late. I've got to get this out on the floor.
4:45 >> Look, give me an hour and a half. An hour? >> Can't do. Has there ever been a time when this didn't assay correctly? No. >> Well, then let them check it out in the granulation or the finished tablet or both. I've got 10 people to answer to and they've all got ulcers. >> In a GMP compliant company, the trained employees know that their work is essential in order to produce a highquality product that will improve and safeguard human life. To give into time pressure at the cost of product quality is something that is unacceptable and dangerous. All their tests have a specific purpose and neglect can lead to a loss of human life. They have strict instructions to report any undue pressure to the head lab technician who will deal with the
5:31 problem. Laboratories or facilities to allow testing of the quality of the various materials used or produced in the manufacturing process should be isolated from the production areas. They should have sufficient space to avoid mixups or crosscontamination. There should be adequate and suitable storage space for equipment and samples, reference standards and records. These standards of high quality can be found throughout the company. For instance, in the warehouse, trained employees make sure that there is sufficient space to allow proper storage of all materials. It is standard GMP practice that all incoming materials be checked and labeled and registered with the company's own labeling system.
6:17 Special storage areas are also available for storing quarantined or recalled products or restricted dangerous drugs. A wellorganized warehouse allows for quick location of goods and minimizes chances for mistakes. >> Where's steroid 47 now? >> Mix. >> Where? over there across number four. >> Would you say that's a little close? >> Normally, yes, but we're up the creek for space. We didn't count on doing this today. >> What's in for still best? I know. Contamination. Crosscontamination. >> So, what about it? >> Well, you're looking at it. The exhaust
7:06 not full. Strained it. I don't know what else we can do unless we cancel the order. >> Let's not do that. To minimize the risk of contamination or serious medical hazard to either workforce or consumer, dedicated self-contained facilities should be used. This is essential where particular pharmaceutical products such as highly sensitizing agents or live biological agents are being produced. All personnel prior to and during employment should undergo regular health examinations. The highest level of personal hygiene should be encouraged and practiced by all staff to avoid contamination of the
7:53 production process. All staff should be instructed to wash their hands and wear clean protective clothing. Used clothing, if to be reused, should be stored in separate closed containers until properly laundered and if necessary disinfected or sterilized. Special protective wear such as gloves, earplugs, and face masks must be worn in designated areas. All persons entering the production area, irrespective of their status or position, should be required to follow the strict hygiene regulations. Areas used for preparing raw materials such as sampling should be separate from other storage and production facilities
8:38 and designed to minimize contamination. All materials should be regularly tested and closely monitored. Incoming containers should be checked for integrity of packaging and seal before sampling. All materials should be stored under the conditions stipulated by the manufacturer and in such a fashion as to allow for first in first out usage. The manufacturing process depends on a team of individuals. The team must work together to achieve their objective. There must be sufficient qualified, trained and experienced personnel at all levels to ensure all tasks for which the manufacturer is responsible to be carried out according to the validated and proven instructions. This is most important during
9:26 documentation and improcess sampling. Only by following these strict regulations can product quality be guaranteed. Before each new run, a thorough cleaning of all equipment, including the tablet compressors, is essential. But not with this brush. It just spreads the residue of the previous batch around. Seems unlikely. Not when a worker hasn't been properly trained, or when the supervisor is girl watching. And so a batch of steroid 47 tablets is being stamped out on equipment that
10:12 still shows the traces of the previous run. After every run, equipment is labeled as used and may not be used again until it has been cleaned. The layout and design of the equipment must aim to minimize the risk of errors and allow effective cleaning and maintenance to be carried out on a regular basis in order to avoid any adverse effects on the product or its constituents. Washing and cleaning equipment should be selected and employed in such a fashion as to not be a source of contamination. After cleaning, equipment must be inspected by a trained and authorized employee. The equipment and all its components must undergo an intensive examination.
10:58 Only after this procedure has been carried out may the required paperwork be completed and the equipment released for reuse. Premises should be laid out so as to allow production to take place in areas connected in an orderly and logical sequence following the sequence of production steps and the requisite level of cleanliness. The orderly and sequential sighting of equipment and materials should be done so to minimize the risk of contamination and so as to avoid the risk of confusion between product or components and to avoid the omission or incorrect application of any of the manufacturing steps or control or handling procedures throughout the whole procedure process.
11:45 documentation must be accurately filled out >> to make certain that all these tablets are of the required weight. This man need only take 10 tablets say each quarter hour and weigh them. That's all. Then if they show up light or heavy, he can readjust his equipment. But when you're one man handling several machines and you're out to meet a deadline, [Music] Each trained employee assigned to a specific piece of equipment is
12:30 responsible not only to ensure that the equipment is functioning, but also to ensure that the product meets set standards. Here, for instance, the employee has access to regularly checked weighing equipment to see if the tablet weight is within allowed tolerance. But this is only one step in product control. In the department in process control, there are a number of tests carried out at regular intervals throughout the production process. This laboratory, like any other laboratory on the premises, must be isolated from the production areas. The tests carried out here allow for adjustments to equipment and mixtures during the production process if necessary.
13:35 [Music] Steroid 47, 2.5 mg per tablet. That's what it says on the labels. Or is it steroid 47 in a bottle accidentally labeled still best 74? You know and I know but will the pharmacist know and what of the patient? Packaging areas should be laid out as to
14:22 avoid mix-ups and crosscontamination. Packaging materials should be checked immediately on delivery for quantity, correct identity, and conformity with packaging instructions. They should be stored in a secure area to avoid unauthorized access. Each batch of printed materials should be assigned a distinct identity code or mark. Roll labels are easier to use and safer than cut labels. Final products should be held in quarantine until released for use by the individual responsible. A batch of steroid 47 under strength and probably contaminated.
15:08 Some underweight, some overweight tablets, some mislabeled. All potentially dangerous. The byproduct of ineffective and sometimes non-existent controls. >> Lot number 3423. We are recalling the entire lot. >> Please discontinue dispensing and send your stock back to our warehouse. You will of course receive full credit. >> It concerns our product zero. >> After a product has been produced and labeled, all the documentation produced throughout the entire process is gathered at one location and checked and sorted. If and only if everything checks out does this documentation reach the desk
15:54 of the head of production. It is his responsibility to recheck the paperwork and give final clearance for distribution. Only now can the goods in quarantine receive the final clearance sticker which allows them to be moved into the warehouse to await distribution. But the process for documentation doesn't stop here. Every carton that is removed from the warehouse is carefully registered and the number of the final release sticker noted. The vehicle driver must also sign for any received goods. GMP is a system that guarantees quality
16:43 control through all aspects of drug and vaccine production. It is the system that protects us all and gives us peace of mind to know that the medicines we give our children will help make for a better, happier life. [Music]
