Batch record keeping

The distribution of medicines from manufacturer to retailer is mainly a private function, the wholesaler covering their costs and earning their profit through the margin allowed in the retail price. The wholesale dealer s licence, among other things, seeks to ensure adequate record keeping, in case a batch of medicines has to be recalled. 

Sometimes interdepartmental roles and responsibilities for batch record development and review can become confused during the drive to bring a new product to the manufacturing floor. The information below intends to provide a guide for each department. Keep in mind that individual companies may have differences from what is written here therefore, it is imperative that these roles and responsibilities are included in SOPs dealing with batch record development, execution, and review. The goal is to make sure that all necessary steps, as listed in this chapter, are fulfilled. This list is by no means all inclusive of every department or of all actions necessary to meet specific internal requirements. 

For whatever work is done during the course of operations, always keep in mind the overall goal. In this case, the final goal of the batch record is to provide a format for the consistent, successful production of a pharmaceutical product. The axiom that Success is 99 % planning and 1% doing holds true for the batch record. That said, the following is a quick list of essential compliance considerations for this planning phase. 

Finally, there is the need for proper documentation, which can be in written or electronic forms. These should cover every step of the measurement process. The sample information (source, batch number, date), sample preparation/analytical methodology (measurements at every step of the process, volumes involved, readings of temperature, etc.), calibration curves, instrument outputs, and data analysis (quantitative calculations, statistical analysis) should all be recorded. Additional QC procedures, such as blanks, matrix recovery, and control charts, also need to be a part of the record keeping. Good documentation is vital to prove the validity of data. Analyt-... 

As previously described, the use of computers and computerized systems in the pharmaceutical industry is growing at a rapid rate. Some of the systems used in the industry range in complexity from the use of personal computers for performing simple tasks (word processing, e-mail, Internet access) to the use of powerful computers in process-control applications. In addition, to help eliminate or reduce paper usage, the pharmaceutical industry has implemented a number of electronic batch record systems in drug substance and product manufacturing to keep track of process documentation. 

In order to allow effective tracking of products, record keeping of product distribution is necessary. Sufficient information on wholesalers and/or directly supplied customers with precise batch numbers and quantities supplied together with contact numbers and addresses must be available and up to date. The process of the recall must be recorded including reconciliation between delivered and returned quantities of the products. 

A part of the analytical planning for a chemical complex is the setting up and maintenance of a sample library, where analyzed samples from each tank car load or reactor lot are stored for reference purposes. The retention time for these samples is set to exceed the probable delay between the time of product shipment and time of final consumption. Thus, if a customer is having difficulty with a particular batch of product, the retained samples enable the company to check the specifications and render rapid technical assistance. Reanalysis of the sample may also be used by the company to accept or reject claims regarding the quality of a product shipment. Thus, proportional process control, raw materials and product, analysis, sample retention, and careful record-keeping all comprise important parts of an operating chemical complex necessary for the maintenance of product quality and customer satisfaction. 

Not only is timely seeding an excellent way to do away with batch-to-batch vagaries in the width and sensitivity ofthe metastable, supersaturated region, but the avoidance of nucleation is often crucial for achieving crystallization elegance—a requisite for enhanced rejection of impurities. To trade away such a powerful tool for the sake of trivially lessened inconveniences in record keeping in a GMP plant is most unsound as an operating principle. For those frequent and difficult purification tasks that crystallization from solution does so well, seed early, seed often and, above all, seed always. 

There should be a written procedure for implementing a manufacturer s product recall, and records of any recalled products received into the warehouse should be kept It is useful to have a record keeping system by batch which would assist with effective recall from the retailer. A person should be designated as responsible for execution and co-ordination of recalls. 

Apparatus. Since all the polymer modification reactions presented in this paper involved gas consumption, an automated gas consumption measuring system was designed, fabricated and used to keep constant pressure and record continuously the consumption of gas in a batch type laboratory scale reactor. Process control, data acquisition, and analysis was carried out using a personal computer (IBM) and an interface device (Lab-master, Tecmar Inc.). 

Since 1970, the date, shift, manufacturer and product name have been printed in code on the cartridge of cap-sensitive high expls. The manufacturer keeps records, by that day-shift code, and can tell to whom each batch of material was sold. Distributors also are required to keep records of sale. It is thus possible, from the date-shift code, to compile a list of last legal purchasers of expls from a lot with the same date-shift code. BATF maintains a National Explosives Tracing Center, whose function is to coordinate this activity. A typical trace would start with the recovery of an undetonated bomb. This code would be telephoned to the tracing center which would forward the information to the manufacturer, who would provide a list of consumers or distributors. If expls from that lot were sold to a distributor or distributors, they would be contacted for a list of retail purchasers... 

In the United States, drug GMPs were formally introduced in 1963 and included the regulation of computer systems. 21 CFR Part 211.2(b) emphasized computer backups and documentation, including keeping hardcopy of master formulas, specifications, test records, master production and control records, batch production records (batch production and control records), and calculations. 

The keeping of a record on the distribution of each batch of product must allow, when necessary, quick and total recall of the production batch. 

There are several reasons why the new flavoring may be rejected. The first is that the compounder might have improperly sampled the batch or even sent the wrong sample. That is why a second sample is always taken. A second cause of rejection may be the use of old stock materials. If old juice concentrates or citrus oils have been used, the finished flavors would exhibit flavor and color changes characteristic of browned or oxidized stock material. Since the compounders keep very extensive data on each flavor they make, it is easy to determine the age of the stock materials used through lot numbers. Also the use of computerized formulations can tie into stock records and expected life of a raw material and teU the compounder that a given raw material needs to be retested prior to use. This helps greatly to eliminate this type of formulation error. 

---