This page describes batch records and has a teaching exercise in which students look for errors in the way in which a batch record is filled out. (Thirty to sixty minutes should be enough for this activity, depending on how much time is spent in discussion.)

Documentation, that is, a system of written records, is essential in all laboratories and production environments. A Batch record is a document that accompanies a pharmaceutical product as it is made. The batch record directs the operators in exactly how to make the product B and the operators must follow the batch record instructions just as it is written. Each time a product is to be made, the operators are issued a fresh copy of the current version of the batch record. The batch record also provides blanks that are filled in as the operator performs each task to document that they have done it. For critical steps, a witness watches the operator and signs off as well.

View the sample batch record for making 6 molar hydrochloric acid. The batch record appears as the operator would first receive it, that is, with the blanks not filled in. Print out this batch record and look for these features:

 TITLE or SUBJECT. The title of the batch record is included on each page. [For example, ACompounding Instructions: 6 Molar Hydrochloric Acid@ is clearly written at the top of each page.]

 ID NUMBER. Each batch record should be also contain a unique identification number.

 PAGE NUMBER. Each page of the batch record should be numbered. [For example the page number is shown on each page of the ACompounding Instructions: 6 Molar Hydrochloric Acid@ in the format of p. 1 of 3 where 3 is the total number of pages in the Batch record.]

 HAZARD COMMUNICATION. This section warns the operator of any hazards associated with the procedure and any required safety precautions. [There are warnings in the ACompounding Instructions: 6 Molar Hydrochloric Acid@ relating to using acids and high temperature water.]

 PROCEDURE. The core of the batch record details what the operator will do in a step-by-step chronological manner. Every batch record has this information. [Observe in the ACompounding Instructions: 6 Molar Hydrochloric Acid@ batch record that as the operator performs each task, s/he fills in related information to document how that task was done. The witness signs the Averified by@ lines.]

 LABEL INFORMATION. Every company will have specific instructions for labeling manufactured products. These instructions must be followed exactly to avoid any mix-ups. [The ACompounding Instructions: 6 Molar Hydrochloric Acid@ batch record includes labeling information.]

 QA REVIEW. Every completed batch record is reviewed by a QA representative to ensure that it is properly filled out.

Now, view the same batch record filled in by an operator and a witness. Apparently, neither the operator nor the witness had their minds on their work! The filled-in batch record has many errors. Pretend that you are an FDA inspector who is reviewing this document. See how many errors you can find. When you are done, check your answers with the answer key.

MORE BATCH RECORDS

The Biotechnology Manufacturing Course at New Hampshire Community Technical College emphasizes proper Documentation principles.  Here are some excellent examples of the use of Batch Records during laboratory exercises.

• Batch Culture of E. coli Recombinant for Jellyfish Green fluorescent Protein

• Batch Culture of Recombinant CHO cells

• Process Controlled Fed-Batch Fermentation of Recombinant HAS Secreting Pichia pastoris

• Isoelectric Focusing of Proteins of Interest of tPA, HAS, BSA, Transferrin, and IgG

• Tangential Flow and Diafiltration of HSA

• Ion Exchange Chromatography of tPA

• HSA Purification using Affinity Chromatography

• SDS-PAGE Analysis of HAS and Purified tPA