Controlled Room Temperature

Hello good people of the world! Today’s post is about controlled room temperature, which is of importance for any space holding drug products, including manufacture, storage, and transportation. Storage temperature requirements are closely related to drug stability, so are an important focus of regulatory agencies.

US pharmacopeia has at least two applicable monographs:

Good Storage and Shipping Practices

and

Pharmaceutical Stability

ISPE summarizes the general industry approach nicely in the Good Practice Guide on Cold Chain Management (not free but available here):

“‘Controlled room temperature’ indicates a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.”

How do you control your room temperature space? Leave a comment below and please share this post with whomever you think would benefit.

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Revision to EudraLex Volume 4 August 2014

Hello good people of the world! Another short post today, this one on the revision to EudraLex Volume 4 (GMPs) dated 13 August 2014. The revision is here. A short revision, the changes include updates to Chapter 3 (Premises and Equipment) and Chapter 5 (Production) around prevention of cross-contamination and qualification of suppliers.

Of note is the increased guidance around the use of quality risk management principles.

The revision will come into affect in March 2015.

What do you think of these changes? How will you adjust your quality program, if at all?

Like this MWV (Mike Williamson Validation) post? Be sure to like, share, and subscribe!

EU Q&A on GDP Guidance

Hello, good people of the world! On March 28, 2014 the European Commission released a question and answer (Q&A) document related to their Good Distribution Practice (GDP) guidance. The original guidance is here. The Q&A document is here. Some highlights:

1. Question: in Chapter 2 – Personnel, 2.5, does the statement “appropriate procedures relating to personnel hygiene, relevant to the activities being carried out, should be established and observed” refer to the health and/or cleanliness of the staff?Answer: It only refers to the cleanliness of the staff, so to avoid any alteration of the product.
2. Question: in Chapter 3 – Premises and Equipment, 3.2.(3), is the intent of segregation to avoid “cross-contamination” as mentioned in chapter 5?Answer: The intent of this provision is to avoid handling errors and accidental swaps of products. This is why electronic segregation is allowed, except for falsified, expired, recalled and rejected products which always have to be segregated physically.
3. Question: concerning Chapter 3 – Premises and Equipment, 3.2.1, how many probes are necessary to monitor the temperature?Answer: The number of probes and their placement depend on the risk analysis performed on the site and the placement should be in agreement with the mapping results.
4. Question: Concerning Chapter 9 – Transportation, 9.2.(1), can we deviate from storage conditions if the manufacturer agrees to the transportation of the product within a certain temperature range (2°-25°c) for a limited time frame of 6 hours?Answer: No. Storage temperature limits as described by the manufacturer or on the outer packaging need to be respected for each stage of transport during the whole transport chain.

Any of these questions or answers leave you with more questions? Leave a comment below and please share this post with whomever you think would benefit.

Qualifying cGMP Warehouse Space

Hello, good people of the world! So you have a cGMP warehouse you need to qualify? Well, this post will provide plenty of information to get you started.

First, how do you know your warehouse is a “cGMP” warehouse. Well, it is if:

• The warehouse will house any raw material, excipient, intermediate, or finished product
• The warehouse will house equipment or process consumables, such as filters, bags, disposable tubing, etc.
• Any cGMP operations will occur in the warehouse, such as sampling, dispensing, kitting, track and trace, etc.

Any examples of common or even possible non-cGMP warehouse space in the Biopharma industry? Please leave a comment below.