Author: Nigel J Smart PhD

As the number of therapeutic targets continues to ramp up both in terms of numbers and complexity, the race for a place to make the product becomes more intense. Companies are left with the age-old conundrum of whether to make or buy…… Meaning, make it in a facility of their own if available, or by space and time in a contract manufacturers facility. Intuitively, companies often tend to want to run in their own facilities to make their own products, because it provides the possibility for more control. However, the simple economics of owning and operating a facility today...

Today more than any time in the past it is vital that we create customer value. How we do that with our pharmaceutical processes is to properly manage those integrated actions that produce results consistently in the most efficient ways, with only the resources that are needed, nothing more nothing less. The competitive environment of the life sciences industry is constantly changing, so organizations need to alter their operating habits to meet the compelling dynamics of the marketplace, if they wish to remain in business, competitive and profitable. Standing still and/or using the same business practices as usual is...

Part 3 The QC Laboratory The laboratory is a special piece of the total site audit and can often require some special considerations. From our experience the laboratory layout can have a major effect on the effectiveness of the unit, because many compliance issues can be linked to mistakes caused by the processing methodology. So, in terms of basics, look at the layout of the laboratory and look for the degree of clutter. If the place is disorganized and/or cluttered, then you’ll almost certainly find lots of compliance related issues. In terms of flow, check on how the samples...

Part 2 The Process Area Important as one starts to review the process area compliance is to monitor the company’s policy on movement in/out of the process area. This ingress/egress can be the first important step in assuring that the product is going to be in compliance. Attitudes towards gowning, such as the use of beard covers, hair covers, shoe covers, non-powder shedding rubber gloves, laboratory coats/bunny-suits and other PPE, will shape the fundamentals for the rest of the operation, so it is important to check this is done properly and that personnel follow the SOP’s in place. Do...

Part 1. The Warehouse. Like most things in life, starting with good preparation is the best way to ensure a good endpoint. In the case of identifying competent and reliable compliant suppliers, this means making sure they have the right skills to do the job. It also means that they can be a reliable on time supplier of the correct quantities of materials required and with the correct specification. Often forgotten by some that are looking for a Contract Manufacturing Organization, is whether they have a solid business financial base to handle the production capacity you require. This can...