FDA Guidance: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products

May 20, 2008

This guidance document provides recommendations to manufacturers, for using methods other than sterility testing to confirm container and closure system integrity as a part of the stability protocol for sterile biological products, human and animal drugs, and medical devices. This guidance document finalizes the draft guidance of the same title dated January 1998 (January 28, 1998, 63 Federal Register (FR) 4272).

The recommendations in the guidance document apply to both pre- and post-approval stability protocols for sterile biological products, human and animal drugs, including investigational and bulk drugs. For medical devices, the recommendations in the guidance document apply to stability protocols for those devices labeled as sterile. The guidance can be downloaded from the FDA website.

FDA Releases Information on Risk Evaluation and Mitigation Strategies (REMS)

May 20, 2008

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if FDA finds that a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks of the product, and FDA notifies the sponsor. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system, and must include a timetable for assessment of the REMS. Some drug and biological products that previously were approved/licensed with risk minimization action plans (RiskMAPs) will now be deemed to have REMS. The FDA answers questions about Risk Assessment and Management Strategy, click here.

GMP Regulation for Medical Devices

May 20, 2008

Process validation is required by the medical device GMP Regulations, 21 CFR Part 820. Section 820.5 requires every finished device manufacturer to:

“…prepare and implement a quality assurance program that is appropriate to the specific device manufactured…”

Section 820.3(n) defines quality assurance as:

“…all activities necessary to verify confidence in the quality of the process used to manufacture a finished device.”

When applicable to a specific process, process validation is an essential element in establishing confidence that a process will consistently produce a product meeting the designed quality characteristics.

A generally stated requirement for process validation is contained in section 820.100:

“Written manufacturing specifications and processing procedures shall be established, implemented, and controlled to assure that the device conforms to its original design or any approved changes in that design.”

Validation is an essential element in the establishment and implementation of a process procedure, as well as in determining what process controls are required in order to assure conformance to specifications.

Section 820.100(a) (1) states:

“…control measures shall be established to assure that the design basis for the device, components and packaging is correctly translated into approved specifications.”

Validation is an essential control for assuring that the specifications for the device and manufacturing process are adequate to produce a device that will conform to the approved design characteristics

Click here for more information

Places near Bangalore / Bengaluru to go

May 20, 2008

1. Nandi Hills

It is the nearest hill station from Bengaluru and a good option for somebody looking to go for a long drive.

To reach Nandi Hills take the Hyderabad highway (NH7/Yelahanka Road) from Bengaluru. After 38kms along the highway, couple of kms past Devanahalli, you can see a road going to the left towards Nandi Hills. There is a sign board there and you should not miss it, if you are careful. After another 10kms you will reach a T-junction, from where you should take a left. 4 more kms, it is one more right turn followed by a ghat road leading to Nandi Hills.The place offers a nice bird’s eye view from the top. An early morning drive to the hills, in time for the sunrise, is an exciting option.

2. Sangam

Sangam is the confluence of Rivers Kaveri (Cauvery) and Arkavathi. One more nice picnic spot along Kanakapura Road (NH209) formed around River Kaveri.

To reach Sangam by taking a 33km deviation to the left, soon after Kanakapura, along NH209. A big arch is placed there to tell you the route. About 16kms from Kanakapura you will reach a junction, to the right of which is Cauvery fishing camp. Go straight for Sangam. The last five kms to Sangam is an enjoyable drive through the ghat roads, with picturesque hills all around you. Water is not so deep at Sangam and is very clean, in spite of the huge crowd generally found here. But the surroundings is filled with litter and plastic. Its a pitty that a place like this is not kept clean.

3. Sivanasamudram

Sivanasamudram (aka Sivasamudram) is a nice waterfall near Malavalli, Mandya district. The waterfall is around 50meters tall on River Kaveri (Cauvery) and is a beautiful sight, especially during monsoon. To reach Sivanasamudram, take the NH209 (Kanakapura road) and continue till Malavalli, past Kanakapura. Around 10kms past Malavalli, along NH209 (Kollegal road), you can spot a board to your left, indicating a 4km detour to Sivanasamudram.

4. Talakkad

Talakkad (Talakad/ Talakadu/ Talakkadu), situated in the banks of Kaveri (Cauvery) is known for its sand dunes and the temples buried underneath. River Kaveri flows very shallow here and is ideal to take bath and play around. Talakkad is in Mysuru (Mysore) district. To reach there, take the NH209 (Kanakapura road) past Malavalli. Soon after Malavalli, there is a T junction, with road on the right going towards Mandya/Mysuru. Take the left and continue in NH209, towards Kollegal. About some 5kms before the detour for Sivanasamudram, there are sign boards indicating Talakkad, 22 kms to the right.

5. Bannerghatta National Park

Located 22 kms from Bengaluru city, along the Bannerghatta road, this is a good place to visit. Just about 10kms from IIMB campus, Bannerghatta national park is probably the easiest place, where you can spot wild animals like lions and tigers roaming freely in something resembling a forest. These animals are kept in fenced containment and safari is arranged to see them. There is also a zoo in the national park premises where you can have a look at a variety of animals. An Elephant joy ride or safari is also possible.

A major drawback with the place is that it is more of a zoo than a national park and lacks a wild feel. Also, the animals kept in cages paints a sorry figure. Still, some of the tigers/lions kept in fenced containment looks healthy, offering a rare experience.

6. Big Banyan Tree (Ramohalli)

18 Kms. from Bangalore on the Mysore Road. The famed Big Banyan tree spread over nearly four acres is located here. The tree has an awe-inspiring appearance and consists of a vertical root system forming a pleasant complex. Age of this massive tree is around four hundred year.

7. Muthyala Maduvu (Pearl Valley)

44 kms from Bangalore via Brigade Road-Hosur Road-Anekal. A picturesque picnic spot with a waterfall which is 300ft. high. There is a Traveller’s Bungalow 6 kms from Anekal Town on the Hosur Road. For reservations contact Block Development Officer, Anekal.

8. Kolar Gold Mines

120 kms from Bangalore. Kolar is as rich in history as it is in gold. The gold mines here are the deepest mining pits in the world, reaching down to a depth of about 10,000 feet below the surface of the earth. The Secratary, Kolar Gold Mining Undertaking, K.G.F., may be contacted for permission to visit the mines. Bharat Earth Movers factory is also situated here.

To find more place please visit click here