Happy Thanksgiving! Don't Miss Our End of Year Events!

Will you be attending any of these events? We hope you will be joining our Subject Matter Experts as they share their insight and expertise on some of the most pressing issues before the close of the year!

IPA'S Good Laboratory Practices

November 30 – December 1, 2010 - Montreal, Canada
Introduction, Requirements and Tools for Implementation

 You've probably met Nancy Tomoney at past conferences - we hope you got a chance to view her presentation at RAPS 2010! If not, please introduce yourself, as Nancy will be attending and presenting at IPA's GLP conference in Canada this year. She joins a high profile panel of speakers with talks on Testing and Reporting Controls, among others.

Click here for more information, or to register for this event.

 
BIOCOM Presents: Off Label Promotion
November 30, 2010 - San Diego, California
Managing the Regulatory Compliance and Products Liability Risks
Alexis Stroud, our Director of Quality and Compliance, is another popular face on our speaking circuit. She is jointly presenting with Medmarc on this topic for BIOCOM members, as well as non-members! This is a must-see presentation that will cover, among other topics:

-Prosecution of off-label promotion as a form of Medicare fraud
-FDA guidance on the dissemination of medical and scientific journal articles;
-The impact of off-label promotion on certain, key products liability defenses; and
-Best practices for preventing off-label promotion.

Click here for more information, or to register for this event.


MASSMedic FDA Update

December 1, 2010 - Waltham, Massachusetts

Important FDA Regulatory News and Policies covered by Dr. Jeffrey Shuren, Director of the Center for Device and Radiological Health

When the FDA has something to say, a lot of people will be listening! So register early and claim your seat at this pivotal end-of-year program. In conjunction with the American Society for Quality/New England Biomedical Discussion Group & the Regulatory Affairs Professional Society/Boston Chapter, QPharma's Fred Sperry and Bruce Fieggen (crowd favorites!) will be giving you some inside info on:

- Project Management - What We All Need to Know

- 21 CFR Part 11 Compliance - What's New

Click here for more information, or to register for this event.

On behalf of QPharma's entire team, we wish you a Happy, Safe, and Fun Thanksgiving!

Recommendations for an Effective Vendor Qualification Program - Part 2 of 2

Written by Teresa Jaworski – Subject Matter Expert, QPharma


In last week’s post, I shared with you some preliminary guidelines for qualifying a vendor. Here is Part 2 of that post:

Pre-Audit Questionnaire

If it is determined that a new vendor is needed, you should select a minimum of three (3) vendors, if possible, which can supply the product or services needed ( raw materials, components, manufacturing equipment, testing equipment, consulting services, etc.). The approved procedure should provide guidance for selecting these vendors. Once the potential vendors are selected, a pre-audit questionnaire should be provided to and completed by each of the potential vendors. The results from the completed questionnaire should be used to determine if the vendor will continue in the qualification process.


Onsite Vendor Audit


If it is determined that the potential vendor meets the criteria for continuing the qualification process per review of the completed questionnaire, schedule an initial, onsite audit as defined in the approved procedures.


When conducting the audit, the appropriate audit checklist should be used according to whether the vendor is defined as a critical or non-critical vendor. In addition, the onsite audit should include verification that the established requirements and specifications can be met by the vendor. Then based on the overall results, the potential vendor can be either accepted or rejected. If accepted, the vendor is considered qualified. If rejected, the company can either work with the vendor to resolve discrepancies and qualify the vendor or select another potential vendor. All auditing activities and results should be documented and maintained.


Quality Agreement


If it is determined that the vendor is qualified, a written Quality Agreement should be developed and approved between the company and the vendor. According to Hasselbalch, “a GMP guidance detailing expectations for quality agreements is in the works as well, and the regulations may be further upgraded to support the guidance in this area. The guidance will explain the expectation that the agreement be in writing and specify clearly what each party commits to do.”


Development and approval of the Quality Agreement should include members from all relevant areas within the company’s organization, including but not limited to quality, procurement, manufacturing, product development, process development, regulatory, and legal. This agreement should define required quality standards; products or services provided; quality requirements and specifications including but not limited to training, qualifications, and monitoring expectations; key contacts; quality roles and responsibilities; locations; and necessary communications regarding quality-related activities.

Recommendations for an Effective Vendor Qualification Program - Part 1 of 2

Written by Teresa Jaworski - Subject Matter Expert, QPharma

According to a June 16, 2010 article posted on the International Pharmaceutical Quality (IPQ) website, FDA Fast-Tracking Supply Chain cGMP Upgrades; Other GMP Changes, Quality Agreement Guidance Taking Shape, “FDA is fast-tracking a set of changes to 21 CFR Part 211 targeting control of raw materials, excipients and components used in pharmaceutical manufacturing.”

The Center for Drug Evaluation and Research (CDER) Office of Compliance Team Leader Brian Hasselbalch announced these impending GMP proposals at a Global Outsourcing Conference at Xavier University on June 14, emphasizing that “adulteration issues represent credible threats to our marketplace and that raw material controls have to be improved.”

Hasselbalch further explained “They will require drug producers to know who the original manufacturer is for all excipients and active ingredients, and any subsequent repackers and relabelers – that you know who they are, who handles [the material] in the supply chain, similarly to the EMA proposed pedigree.”

As discussed earlier in a September 2010 blog, the U.S. Food and Drug Administration (FDA) Guidance for Industry Q10 Pharmaceutical Quality System, which is in accordance with 21 CFR Part 820.50, specifies that Pharmaceutical companies are ultimately responsible for ensuring that processes are in place to assure the control of outsourced activities and quality.  We are now going to dig a little deeper to discuss how these controls can be accomplished.

A company should establish and implement processes that can determine the suitability and competence of a vendor for their specific needs.  These processes should include establishing approved procedures; performing audits; ensuring the vendor is qualified prior to selecting them as a vendor; and continuing to monitor the vendor’s performance after qualification including re-qualifying the vendor at established time intervals.

Establishing Approved Procedures

When establishing approved vendor qualification procedures, keep in mind that the procedures should include, at minimum, guidelines for the following:

• selecting a potential vendor for the products or services needed
• defining and documenting requirements and specifications to be met by the vendor
• determining whether the vendor is a critical or non-critical vendor
• auditing requirements for both a critical and non-critical vendor
• distributing the pre-audit questionnaire for completion by the potential vendor
• determining the vendor suitability as a result of the completed pre-audit questionnaire
• planning, scheduling and conducting on-site vendor audits
• preparing audit reports
• following up on any audit findings to ensure appropriate CAPAs have been implemented
• defining time intervals for re-qualifying/re-auditing vendor
• completing and maintaining vendor Quality Agreements
• developing and maintaining an Approved Vendor List
• storing all required vendor qualification documentation including pre-audit questionnaires, audit checklists and notes, audit reports, Quality Agreements, Approved Vendor List, etc.
• handling vendor relationships when requirements are no longer being met

It is also recommended that the following templates be included, or their location referenced, in the vendor qualification procedures to ensure consistency and to ensure that requirements are being met:

• Pre-audit Questionnaire, which should comprise requests for relevant information  such as the following:
• company name
• company location
• contact information (telephone, fax, email)
• company history
• product(s) or service(s) provided
• number of employees
• details of implemented quality systems
• dates of last regulatory audits (FDA, ISO, etc.)
• Audit Checklist for auditing critical vendors
• Audit Checklist for auditing non-critical vendors
• Audit Report
• Quality Agreement
• Approved Vendor List

Training should be conducted and documented on the approved procedures prior to being used, emphasizing the need for quality support during all phases of the vendor qualification process.

Stay tuned for Part 2, coming next Monday, November 15th!

The Twelve Towers - A Project Management Novel: Excerpt 1 - The Project Charter

Below is an excerpt from the Project Management novel Bruce Fieggen, QPharma’s V.P. of Project Management, is writing in his ‘spare time’. The book follows the Project Management Body of Knowledge Guide (PMBOK) but uses the format of a novel, and promises to be much more readable. The novel tells the story of a Gwilym, a Project Manager, charged with building twelve towers scattered throughout King Arthur’s Britain. Gwilym has three sons, the oldest of whom, Bleddyn, is also introduced in this excerpt.

Readers, think about the various projects you are tasked with and see how you can use the tools shown in these blog posts to assist you in ‘building your towers’.

This first excerpt shows the development of the first tool: The Project Charter.

After laying down the foundation logs, the men started laying down the side logs, marveling how each fit neatly into place on top of the one below and to right angles with it. With each additional log, the structure pulled tighter together.

Once the men had the hang of the design, Gwilym left Fred in charge and rode his horse painfully and slowly to the quarry to see about some new stone to dress the tower’s outside. Some stones had been salvaged from the old tower, but much more needed to be added. The quarry was around the other side of the hill but it still took Gwilym two hours of careful riding to reach there given his painful leg. On arriving he asked to sit down and put his leg up.

The quarryman was a short, barrel-chested, old man with sinewy arms and a grizzled beard. “I thought it about time you came to me for stone. How much will ye be wanting?”

“I need 100 tons for now, cut square about 2 feet to a side. When can you deliver that much?”

“I can start delivering 2 tons at a time as soon as I get gold for first shipment.”

Gwilym looked confused and said, “But Father Drew said that the quarry belongs to the church and it is his to use.”

“Aye, church owns it but tower is being built for defense of city. So money must come from king.”

“But Father Drew appointed me the Project Manager. He is the one in charge of the tower. And he is of the church.”

“Father Drew is priest of village church. Quarry belongs to whole church. And for that, you either pay me gold or get permission from bishop.”

“Start cutting now, quarryman. I’ll get the permission in time to take shipment.” Gwilym limped off to his horse and rode painfully back to the village.

                           ___________________________

“How goes the tower, Gwilym?” were Merlin’s first words.

Gwilym was intimidated by this old man of whom he had heard many stories. He looked like the wise old Druid he was reputed to be and his bright eyes sparkled under his bushy eyebrows. His long, grey hair made him seem much older than he was. His hands were strong and showing no signs of age and his well muscled arms handled the reins expertly.

“It goes well sir. The wooden structure is almost finished and we now need to face it with stone.” Gwilym remembered yesterday’s confrontation at the quarry and his mind switched to this other problem in his life. “But now the quarryman wants to charge us for stone, even though the quarry belongs to the church.”

“And what will you do to solve this?”

“I’ll get an order from the bishop to make him give up the stone.”

“And will that be your answer to the next problem that arises?”

“What’s that sir?”

“What will you do the next time you run into a problem like this with your tower?”

Gwilym felt like a fool. What was he missing? “I can’t guess all the problems that will arise; I just have to deal with them as they come up.”

“What will you do if the men decide to stop working? Or if the priest says he wants the tower to be taller, or if some knight asks that it be made round?”

“I need a letter that says what the tower should be and who is to pay for it. And I need it signed by someone whom everyone respects. Like the king! Even the bishop has to listen to the king. Is that what I need, Merlin?”

Merlin’s eyes twinkled but he said nothing. Gwilym looked at him curiously and said, “You know a lot more about building towers than you let on and I’m onto you. Can I ask you other questions later on when I hit other snags?”

“Did I answer your first one?”

“Not with an answer; that’s true, but you asked the right questions that let me come up with the right answer.”

                                      ____________________________

When Sir Kay escorted Gwilym and his son, Bleddyn, into the great hall...