Labeling and Record Keeping

The Government of Myanmar has introduced a licensing requirement and an import and export authorization system for all substances listed in Tables I and II, as well as for caffeine and thionyl chloride. The new legislation also contains provisions on inspection, labelling and record-keeping. Non-compliance with the provisions of the regulation may be punished by imprisonment for a term that may extend from a minimum of 5 years to a maximum of 10 years. 

The storage, trade and distribution of pharmaceutical products are carried out by various companies, institutions and individuals. The nature of the risks involved, however, is likely to be the same as those in the manufacturing environment, e.g. mix-ups, contamination and cross-contamination. There are thus aspects of distribution to which the principles of GMP should be applied. These include, but are not limited to, storage, distribution, transportation, packaging, labelling, documentation and record-keeping practices. 

The HCS requires information on hazardous chemicals to be transmitted to employees through labels, material safety data sheets (MSDS), and training programs. A written hazard communications program and record keeping are also required. 

The standard specifies universal precautions, engineering and work practice controls, personal protective equipment, and housekeeping, combined with HBV vaccinations/post-exposure follow-up, hazard communication labels/signs, record keeping and training, to reduce occupational exposure for all employees exposed to blood and potentially infectious materials. Meeting these requirements is not optional to employers or employees it is now required by law. 

A system of record keeping must be used which eliminates any risk of confusing the samples. As a rule, samples should be recorded immediately after their arrival and, especially in the case of nonfrozen field samples, prior to preparation for analysis. A record should also be kept of the condition of the samples upon arrival at the receiving laboratory and of any packaging or labeling defects. 

All aspects of the laboratory s work which might affect the validity of the final result should be inspected. This will include, for example, documentation, equipment, calibrations, methods, materials, record keeping, sample recording, labelling, quality control checks and log of daily checks, among many others. Some aspects, however, are outside the scope of such an audit, such as safety and security matters, which usually have separate arrangements for auditing. 

There are also general guidelines for such matters as the issuing of prescriptions, record keeping, labeling of packaging, prohibition on advertising, and control of import and export of these substances. 

The QAU must perform routine internal audits to assure that the laboratory facilities are in compliance. Internal audits should include calibration procedures and records, chemical and reagent labeling and expiration dating, and laboratory record keeping and data handling. 

I have provided your supervisors with copies of a document on MSDSs that should be very helpful as you proceed in this work. It is a section entitled Exploring MSDSs found in the book Building Student Safety Habits for the Workplace, published by Terrific Science Press at the Center for Chemical Education at Miami University, Middletown, OH. This section includes a set of instructions for doing exactly what is required for this project (Exercise 3B). I also have made photocopies of the labels in question (found in Section 2B in the above referenced book) and the MSDSs (found in Section 3B in the above referenced book). Also, your supervisors will decide who should evaluate which labels. I have recommended that each participant be assigned two of the four chemicals (four labels) at random, meaning that each participant will each have four labels to evaluate, a consumer product label and an industrial chemical product label for one chemical and a consumer product label and industrial chemical product label for a second chemical. Please use the method suggested for Exercise 3B in the book referenced above and keep a good record of your work in your notebook so that you can prepare a quality report memo for WSHA. 

Biological Collection. Refer to USACHPPM s TG No. 211 for radiobioassay collection, labeling, and shipping requirements. If the patient urinates, the urine should be saved for analysis for radiological contamination. Normal urinalyses can be done on portions of the sample with safety, but the laboratory should be notified that there is a potential contamination with radioactive material. It is essential that the laboratory keep a record of the volumes of urine so those appropriate laboratories can make later calculations of estimated body burdens of radioactive materials. Fecal samples should also be taken and retained in addition to nose blows and swabs. 

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