Is it Possible? Validating Excel Spreadsheets


Shocking news on the Internet:

88% of spreadsheets have errors. Assuming this is true, and the pharma, biotech, and med devices are not immune, we could have quite an issue at hand.

Spreadsheets (especially Microsoft Excel) are pervasive in office environments, and there’s no doubt Excel spreadsheets are employed for GMP uses.

One of the principle concerns is the Microsoft Excel is not 21 CFR Part 11 complaint out of the box, in that it does not include an audit trail or electronic signature. Does this mean Excel should not be used for any GMP purpose? Continue reading Is it Possible? Validating Excel Spreadsheets


The Validation Master Plan


The first question you may ask is: Is a validation master plan required to be compliant with the cGMPs?

The literal answer is no, in fact no regulation specifically calls for a VMP and the only guidance in which the concept shows up is PIC/S’ document PI-006-03, although ISPE has been using the term as early as 1998 (see ISPE Baseline Guide volume 2, first edition, 1998). Euralex Volume 4, Annex 15, published in 2001 references the PIC/S guidance and formalizes the VMP as an integral part of “planning for validation.”

However, I’ve never seen an FDA warning letter that cites the lack of a validation master plan, but there are warning letters dealing with issues in a company’s VMP or failure to follow their own VMP.

Does that mean you shouldn’t waste your time? Continue reading The Validation Master Plan

Ship It! Shipping Qualification 101


Shipping Qualification is one part of the qualification of a drug’s supply chain qualification that protects the quality of a regulated drug product. Other parts include qualifying/auditing suppliers, testing raw materials, manufacturing processes, warehousing, etc.

Shipping Qualification focuses on the parameters that may affect critical quality attributes such as temperature, humidity, light exposure, vibration exposure, etc. You must know your product and the risks associated to it through each of these avenues.

Shipping Qualification is particularly important because some degree of control is lost in shipping product, and the new risks must be understood and mitigated if not acceptable. Continue reading Ship It! Shipping Qualification 101