CLASSROOM ACTIVITY: Exploring The FDA Website And The Good Manufacturing Practice Regulations
This computer activity was developed by the Professional GMP trainer, James C. Gerner, Ed.D., M.S., M.T. (ASCP), E-mail: JCGerner@MSN.com
Purpose:
This is a computer laboratory activity that will give you the opportunity to look at the federal regulations pertaining to pharmaceutical manufacturing. In particular, we will examine those regulations that pertain to a laboratory in a company that produces pharmaceuticals. As you go through this activity, you will get the “flavor” of these laws and will learn how to access them on the computer. Remember that the particular regulations that you will read are small parts of a comprehensive quality system that is intended to protect the quality of pharmaceutical products.
Activities:
Before Going to the Computer Laboratory:
In the Computer Laboratory:
- You will be assigned one or two subparts and sections of the GMP Regulations. On a computer, find the sections you have been assigned.
- Prepare a brief bullet-point summary of the assigned Subparts and Sections of the GMP Regulations on overhead transparencies. Use one transparancy per section. Try to pick five to seven bullet points for each subpart. Remember that your team should not rewrite the regulation, but instead simply summarize the content in a bullet point outline.
- Once your bullets are complete for each Subpart and Section, mark each bullet point as follows:
- Place a circle next to any bullet where a procedure is required. (A procedure tells workers what they are going to do and how to do it.
- Place a square next to each bullet point where a record is required. (A record states what a worker did.)
- Place both a circle and a square next to each bullet point where both a procedure and record are required.
- Present your group’s bullet point summary.
- On a separate sheet of paper, explain in your own words how the GMP regulations together outline the pieces of a quality system for a laboratory in a pharmaceutical company. Consider all the groups’ presentations.
- If you have time, read the definitions in Part 210 and identify those that seem most important to laboratory personnel.
Sections That Have Key Regulations Relating To Lab Personnel:
| Subpart B |
211.22* |
| 211.25 |
| 211.28 (a)(b) |
| 211.42 |
| Subpart C |
211.42 (c)(1)(9) |
| Subpart E |
211.80 (a) |
| 211.82 (b) |
| 211.84* |
| 211.87* |
| 211.94 (d) |
| Subpart F |
211.110 (a)(b)(c)* |
| 211.113* |
| Subpart G |
211.122 (a)(b)(c) |
| 211.134 |
| 211.137 |
| Subpart I |
entire subpart |
| 211.160* |
| 211.166* |
| Subpart J |
211.180 (a)(b)(e)(f) |
| 211.184 (a)(b)(d) |
| 211.186 (a)(b9) |
| 211.188 (5)(10) |
| 211.194* |
| 211.198 (a) |
| Subpart K |
211.208 |
* Particularly important sections
Key Definitions In Part 210 For Laboratory Personnel
(Your answers may be a little different.)
Definition numbers:
| 2 |
11 |
| 3 |
12 |
| 4 |
15 |
| 7 |
16 |
| 8 |
20 |
| 9 |
21 |
| 10 |
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The printable version of this document.
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