Proudly Serving Alaska

---

Alaska Pharmaceutical Software Since 2012

Keep momentum and stay on-top of pharmaceutical regulatory compliance.

Next time your in a pharmacy look around then contemplate how one would run a pharmacy, keep up with the drugs, health care patient information, physician orders and government requirements.  It's a daunting task.  Imagine now what it's like to work behind the scenes at a pharmaceutical facility.

Alaska Customers

Some information I know about Alaska is I believe the state was admitted or ratified to the United States around or about 'January 3, 1859'.  Alaska is located around latitude '66.160507' and longitude of '-153.369141' and has a population of roughly '733,391 million'.  If I remember correctly the capital is 'Juneau' and the largest city is 'Anchorage'. 

Pharmaceutical Manufacturing

Above is an image of an gelcap encapsulation machine.  This is the type of machines Banner Pharmacaps utilized for production of gelcaps for fish oil etc.  I utilized Metler Toledo scales attached via a serial cable/port to a PC which allows software I created to determine gelcap weight when performing cycle tests.  Adjustments were made to the encap machine where needed when gelcap weights were out of thresholds.  Also critical to the cycle tests was the microscope view of gelcaps for outer thickness to eliminate leakers.

Pharmaceutical Experience

To work on computer systems in IT I had to dress up like a cafeteria worker in FDA approved clothing and work on computer systems and software in a FDA production facility where products were being developed for injestion like gel-caps.

If at any point you decide to reach to me just know the area code I work within for Alaska is '907'.  For Pharmaceutical assistance you will find my rates very reasonable for Alaska.  Now just keep in mind my time zone is 'Eastern Standard Time (EST)' and I know the time zones in Alaska are 'Alaska Standard Time (AKST)' in case you wish to call me.  Anyway let me continue.

Regulatory Requirements

Software for the pharmaceutical industry involves first and foremost the understanding of FDA regulations the term validation.  In the pharmaceutical, medical device, food, blood establishments, tissue establishments, and clinical trials industries, validation is the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results.  It often includes the qualification of systems and equipment.  It is a requirement for good manufacturing practices and other regulatory requirements.  Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:

1. Cleaning validation
2. Process validation
3. Analytical method validation
4. Computer system validation

Similarly, the activity of qualifying systems and equipment is divided into a number of subsections including the following:

1. Design qualification (DQ)
2. Component qualification (CQ)
3. Installation qualification (IQ)
4. Operational qualification (OQ)
5. Performance qualification (PQ)

Internal CMMI Audits

Internal Audits (SCAMPI Class A, B, C)

I utilize CMMI (Capability Maturity Model Integration) internal audits to link organizational activities to business objectives.  I utilize CMMI to guide the process improvement across a project, a division, or your entire organization.  So how does CMMI help?  It helps integrate traditionally separate organizational functions, set process improvement goals and priorities, provide guidance for quality processes, and provide a point of reference for appraising current processes.

I work with your Director of QA to define auditing approach to ensure coverage of critical activities and CMMI compliance and appraisal readiness.  Let's take a look at my audit steps.

1. I develop and maintain review / audit checklist and other related materials
2. I conduct internal audits / reviews using checklists and interviews with stakeholders
3. I document internal audit / reviews results, improvement opportunities, deficiencies and discuss results with stakeholders. 
4. I provide oversight of auditing activities including tracking and reporting of defects.  Escalate quality and compliance issues as needed.  I track deficiencies to resolution and related action items.

Internal FDA Validation Audits

Common in any pharmaceutical shop is the process of FDA Validation assessments.  Typically done through an internal Validation departments this process evaluates GAMP5 and GMP processes as it relates to FDA controlled environments.  Let's take a look at what is involved.

1. I work closely with your Validations department to ensure all FDA guidelines are followed
2. I conduct internal audits / reviews using checklists for processes / procedures
3. I document internal audit / reviews results for GAMP5 / GMP audit readiness.
4. I provide oversight of auditing activities, defects and training issues

History

The concept of validation was first proposed by two Food and Drug Administration (FDA) officials, Ted Byers and Bud Loftus, in the mid 1970's in order to improve the quality of pharmaceuticals (Agalloco 1995).  It was proposed in direct response to several problems in the sterility of large volume parenteral market.  The first validation activities were focused on the processes involved in making these products, but quickly spread to associated processes including environmental control, media fill, equipment sanitization and purified water production.

The concept of validation was first developed for equipment and processes and derived from the engineering practices used in delivery of large pieces of equipment that would be manufactured, tested, delivered and accepted according to a contract (Hoffmann et al.  1998).  The use of validation spread to other areas of industry after several large-scale problems highlighted the potential risks in the design of products.  The most notable is the Therac-25 incident, (Leveson & Turner 1993).  Here, the software for a large radiotherapy device was poorly designed and tested.  In use, several interconnected problems led to several devices giving doses of radiation several thousands of times higher than intended, which resulted in the death of three patients and several more being permanently injured.

In 2005 an individual wrote a standard by which the transportation process could be validated for cold chain products.  This standard was written for a biological manufacturing company and was then written into the PDA's Technical Report # 39, thus establishing the industry standard for cold chain validation.  This was critical for the industry due to the sensitivity of drug substances, biologics and vaccines to various temperature conditions.  The FDA has also been very focused on this final area of distribution and the potential for a drug substances quality to be impacted by extreme temperature exposure.

Reasons for validation

Validation is "Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes." (FDA 1987).  A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation.  Testing a sample of a final product is not considered sufficient evidence that every product within a batch meets the required specification.  It really takes a dedicated individual who knows this area.  You know speaking of area.

You know, I don't make it out to Alaska much but I would like to see the 'Willow Ptarmigan' state bird.  I am a little familiar with the Alaska 'Forget-me-not' state flower as well.  However, I do not know much about Alaska's state tree the 'Sitka Spruce'.  Fishing is fun to me perhaps I would like reeling in the Alaska 'Largemouth Bass' state fish.  Anyway, sorry I went off topic.  Let me continue.

The validation process

The validation process consists of identifying and testing all aspects of a process that could affect the final test or product.  Prior to the testing of a process, the system must be properly qualified.  Qualification includes the following steps: (These steps are common practice for equipment IQ, OQ and PQ).

1. Design qualification (DQ)- Defines the functional and operational specification of the instrument, program, or equipment and details the rationale for choosing the supplier.
2. Installation qualification (IQ) - Demonstrates that the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.
3. Operational qualification (OQ) - Demonstrates that all facets of the process or equipment are operating correctly.
4. Performance qualification (PQ) - Demonstrates that the process or equipment performs as intended in a consistent manner over time.
5. Component qualification (CQ) - is a relatively new term developed in 2005.  This term refers to the manufacturing of auxiliary components to ensure that they are manufactured to the correct design criteria.  This could include packaging components such as folding cartons, shipping cases, labels or even phase change material.  All of these components must have some type of random inspection to ensure that the third party manufacturer's process is consistently producing components that are used in the world of GMP at drug or biologic manufacturer.

There is often overlap between Installation, Operational, and Performance Qualification and sometimes these are performed simultaneously.