Question

GMP is important while formulating the dosage form. In this regard, answer the following question:

1) What is the benefit of good clinical practice (GCP)?

2) What are the different GMP criteria for packaging final products?

3) What is the principle of products recalls?

4) Write the special storage conditions for solid dosage forms?

Answer 1

ANSWER1) The principles of Good Clinical Practice (GCP) help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting of clinical trials.  
GCP training aims to ensure that:

• the rights, safety, and well-being of human subjects are protected
• clinical trials are conducted in accordance with approved plans with rigor and integrity
• data derived from clinical trials are

The conduct of clinical research in accordance with the principles of GCP helps to ensure that clinical research participants are not exposed to undue risk, and that data generated from the research are valid and accurate. By providing a basis both for the scientifi c and ethical integrity of research involving human subjects and for generating valid observations and sound documentation of the fi ndings, GCP not only serves the interests of the parties actively involved in the research process, but also protects the rights, safety and wellbeing of subjects and ensures that investigations are scientifi cally sound and advance public health goals.

ANSWER 2

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards.” “...GMP covers all aspects of production, from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the fi nished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time the product is made.” Compliance with GMP standards is intended to:

• assure consistency between and within batches of the investigational product and thus assure the reliability of clinical trials;

• assure consistency between the investigational product and the future commercial product and therefore the relevance of the clinical trial to the effi cacy and safety of the marketed product

; • protect subjects of clinical trials from poor-quality products resulting from manufacturing errors (omission of critical steps such as sterilization, contamination and cross-contamination, mix-ups, incorrect labeling, etc.), or from starting materials and components of inadequate quality; and

• document all changes in the manufacturing process.

ANSWER 3)

A procedure of retrieval or withdrawal of products known or suspected to be defective, promptly and effectively, from the market

According to Product Recall Principle “There should be a system to recall from the market promptly and effectively, products known or suspected to be defective".The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization, and do not place the patient at risk because of inadequate safety, quality or efficacy.Recalls must be handled positively and carefully reviewed, and actions must be taken as necessary leading to an effective recall of defective product from all markets where it has been distributed.

ANSWER4)

Storage is an important aspect of the total drug control system. Proper environmental control (i.e., proper temperature, light, and humidity, conditions of sanitation, ventilation, and segregation) must be maintained wherever drugs and supplies are stored in the premises.

The stability of product retain within the specified limit, throughout it period of storage and use

1. Precautions that should be taken in relation to the effects of the atmosphere, moisture, heat and light are indicated. During storage of the pharmaceutical products is one of the fundamental concerns in patient care

2. The conditions under which pharmaceutical products are manufactured and stored can have a major impact on their Quality. High temperature and relative humidity (RH) are the most important factors involved in drug degradation

3. Factors such as temperature, humidity, air quality, time and production process characteristics can all have a significant impact on the final quality, and therefore the saleability, of a product or batch of products.

For many products requiring storage in cool conditions, refrigeration plant is widely used, which needs to be carefully monitored to ensure that the correct temperatures are maintained. Stock must be stored in appropriate and auditable environmental conditions.

The following factors to be taken in consideration for proper storage:

1. Sanitation

2. Temperature

3. Light

4. Moisture

5. Ventilation

6. Segregation

Different pharmaceutical product storage temperature on the basis of stability studies as given

below:

Freezer: A place in which the temperature is maintained thermostatically between -25ºC and – 10ºC (-13 ºF and -14 ºF).

Cold: Any temperature not exceeding 8ºC (46 ºF). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2ºC and 8ºC

Cool: Any temperature between 8 ºC and 15 ºC. Any pharmaceutical products for which storage in a cool place directed may, alternatively, be stored in a refrigerator, unless otherwise specified in the individual monograph.