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If you have experience in Pharmaceutical market and want to start your own pharma company. These are steps for starting Pharma Company in India. For more information visit http://www.pharmaadda.in/how-to-start-a-pharma-company-in-india
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Regulating the manufacture of therapeutic goodsTGA Australia
View this presentation for information on:
*how the manufacture of therapeutic goods is regulated
* how the quality of therapeutic goods is checked
* differences for higher, medium and lower risk products
* inspections of manufacturers, both in Australia and internationally
* international harmonisation.
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Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
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2. Introduction
• Third-party pharma manufacturer
is a term used to describe a
company that produces drugs on
behalf of another company.
• The third-party manufacturer is
responsible for the entire
production process, from raw
materials to finished products.
• Third-party manufacturing is a
common practice in the
pharmaceutical industry.
3. Why Use a Third-Party Pharma
Manufacturer?
• Cost savings: Outsourcing manufacturing
can reduce costs related to equipment,
labor, and raw materials.
• Access to expertise: Third-party
manufacturers often have specialized
knowledge and expertise in the production
of certain drugs.
• Time savings: Outsourcing manufacturing
can speed up the time to market for a
drug.
4. Types of Third-Party Pharma
Manufacturing
• Contract manufacturing: the third-party
manufacturer produces drugs for a
specific company according to a
contract.
• Private label manufacturing: the third-
party manufacturer produces drugs that
are sold under the brand name of the
company that contracted them.
• Over-the-counter (OTC) manufacturing:
the third-party manufacturer produces
drugs that are sold to the public without
a prescription.
5. Benefits of Third-Party Manufacturing
• Flexibility: Outsourcing manufacturing
allows companies to scale up or down
production as needed.
• Quality control: Third-party manufacturers
often have rigorous quality control
measures in place to ensure the safety and
efficacy of drugs.
• Regulatory compliance: Third-party
manufacturers must meet the same
regulatory standards as the companies they
are producing drugs for.
6. Challenges of Third-Party
Manufacturing
• Quality control: Although third-party
manufacturers have quality control
measures in place, it can be difficult for
the contracting company to monitor
these measures.
• Intellectual property: There is a risk that
a third-party manufacturer could steal
intellectual property from the
contracting company.
• Communication: Effective
communication between the contracting
company and the third-party
manufacturer is crucial for successful
outsourcing.
7. Considerations When Choosing a
Third-Party Manufacturer
• Reputation: It is important to
choose a third-party manufacturer
with a good reputation for quality
and reliability.
• Expertise: The third-party
manufacturer should have expertise
in the production of the specific
drug or drugs being outsourced.
• Location: The location of the third-
party manufacturer can impact
shipping costs and time to market.
8. Conclusion
• Third-party pharma manufacturing
is a common practice in the
pharmaceutical industry.
• Outsourcing manufacturing can
provide cost savings, access to
expertise, and time savings.
• When choosing a third-party
manufacturer, reputation, expertise,
and location should be considered
to ensure a successful outsourcing
partnership.