Pharmaceutical Compliance
Processes of Complying with Pharmaceutical Compliance
Product Safety
The intention of Quality by design Program is to build the quality into a pharma product while it is still in the research and development phase to make sure that final product is going to meet with established standards long before it enters the production phase. One particular industry that has begun to invest heavily in the quality by design program is the pharmaceutical industry where many problems have been occurring with alarming frequency in recent years.
Quality by Design Training
The FDA has been quick to acknowledge the concept and recommend QbD training for all pharmaceutical manufacturers where so many quality issues have plagued the industry for years. Implementation of QbD training will result in far less need for heavy regulatory oversight and will help to streamline the development and manufacturing process. Viral Safety
Any biopharmaceutical products derived from animal or human tissues are needed to be tested to examine their ability to produce safe products to be used in human beings. Ensuring the inactiveness or absence of viruses is made mandatory by the regulators. However, the process of ensuring safety of the medicine and meeting regulatory expectations is expensive and at the same time complex too. Radiopharmaceuticals
Radiopharmaceutical is a radioactive pharmaceutical or chemical component required for diagnostic or remedial purposes. Radiopharmaceuticals for injection require complying with the radiation protection regulations and also apposite regulations for working in aseptic condition. All these regulations have been covered in the Good Radiopharmacy Practice guidelines. Working with radiopharmaceuticals involves a great amount of risks and the risks depend on the types of emission and the half-lives of the radioactive isotopes. Toxicology in Drug Development
A branch of medicine and biology studying the negative impact of chemicals on living organisms is known as Toxicology. Moreover, Toxicology is the study of symptoms, investigation, and cure of poisoning of human beings.
Pharmaceutical Compliance and SOX
The regulations set forth in this part and in parts 211 through 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess. OIG Pharmaceutical Compliance Guidance
OIG, the Office of the Inspector General of the U.S. Department of Health and Human Services published Compliance Program Guidance for Pharmaceutical Manufacturers on April 28, 2003. The present guidance deals specifically with the health care industry. Goal of the guidance is to recommend pharmaceutical manufacturer to be compliant with existing health care laws and regulations which includes False Claims Act, Medicaid Drug Rebate Act etc. Pharmaceutical CGMPs for the 21st Century Initiative
In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative . The Agency's stated intent was to integrate quality systems and risk management approaches into its existing programs with the goal of encouraging industry to adopt modern and innovative manufacturing technologies.
DA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations
This guidance is intended to help manufacturers implementing modern quality systems and risk management approaches to meet the requirements of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211). The guidance describes a comprehensive quality systems (QS) model, highlighting the model's consistency with the CGMP regulatory requirements for manufacturing human and veterinary drugs, including biological drug products. The guidance also explains how manufacturers implementing such quality systems can be in full compliance with parts 210 and 211. This guidance is not intended to place new expectations on manufacturers, nor to replace the CGMP requirements. Readers are advised to always refer to parts 210 and 211 to ensure full compliance with the regulations.
Any pharma company need to follow the below given processes to be complaint with the pharmaceutical compliant:
- Written policies and procedures implementation;
- Organizing effective training and education for the employees;
- Appointing compliance officer and forming compliance committee monitoring progress towards compliance;
- Regular internal monitoring and auditing;
- Establishing effective communication;
- On time responding to address detected problems and taking up corrective action; and
- Enacting standards and disciplinary guidelines.
Product Safety
It is vital that product safety information is collected, reviewed, assessed and reported to the highest standards
Failure to ensure product safety can ultimately result into:
- Affecting the well-being of patients
- Jeopardizing the key relationship between a company and regulators
- Jeopardizing reputation and share price of a company.
The intention of Quality by design Program is to build the quality into a pharma product while it is still in the research and development phase to make sure that final product is going to meet with established standards long before it enters the production phase. One particular industry that has begun to invest heavily in the quality by design program is the pharmaceutical industry where many problems have been occurring with alarming frequency in recent years.
The FDA has been quick to acknowledge the concept and recommend QbD training for all pharmaceutical manufacturers where so many quality issues have plagued the industry for years. Implementation of QbD training will result in far less need for heavy regulatory oversight and will help to streamline the development and manufacturing process. Viral Safety
Any biopharmaceutical products derived from animal or human tissues are needed to be tested to examine their ability to produce safe products to be used in human beings. Ensuring the inactiveness or absence of viruses is made mandatory by the regulators. However, the process of ensuring safety of the medicine and meeting regulatory expectations is expensive and at the same time complex too. Radiopharmaceuticals
Radiopharmaceutical is a radioactive pharmaceutical or chemical component required for diagnostic or remedial purposes. Radiopharmaceuticals for injection require complying with the radiation protection regulations and also apposite regulations for working in aseptic condition. All these regulations have been covered in the Good Radiopharmacy Practice guidelines. Working with radiopharmaceuticals involves a great amount of risks and the risks depend on the types of emission and the half-lives of the radioactive isotopes. Toxicology in Drug Development
A branch of medicine and biology studying the negative impact of chemicals on living organisms is known as Toxicology. Moreover, Toxicology is the study of symptoms, investigation, and cure of poisoning of human beings.
Not only for medical and biology, but often the concept of toxicology is used for other areas such as Aquatic toxicology, Chemical toxicology, Environmental toxicology and so on.
Pharmaceutical Compliance RegulationsPharmaceutical Compliance and SOX
Pharmaceutical manufacturers have always shown commitment to comply with SOX. Failure to comply with SOX can fetch severe legal consequences such as fines and detention. Therefore, each employee of a pharma company is required to make a positive and significant contribution towards SOX compliance. Only collective effort will help the company to monitor and rectify any potential risks, implement efficient and automated procedures to identify and report activities associated risks.
21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; GeneralThe regulations set forth in this part and in parts 211 through 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess. OIG Pharmaceutical Compliance Guidance
OIG, the Office of the Inspector General of the U.S. Department of Health and Human Services published Compliance Program Guidance for Pharmaceutical Manufacturers on April 28, 2003. The present guidance deals specifically with the health care industry. Goal of the guidance is to recommend pharmaceutical manufacturer to be compliant with existing health care laws and regulations which includes False Claims Act, Medicaid Drug Rebate Act etc. Pharmaceutical CGMPs for the 21st Century Initiative
In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative . The Agency's stated intent was to integrate quality systems and risk management approaches into its existing programs with the goal of encouraging industry to adopt modern and innovative manufacturing technologies.
DA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations
This guidance is intended to help manufacturers implementing modern quality systems and risk management approaches to meet the requirements of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211). The guidance describes a comprehensive quality systems (QS) model, highlighting the model's consistency with the CGMP regulatory requirements for manufacturing human and veterinary drugs, including biological drug products. The guidance also explains how manufacturers implementing such quality systems can be in full compliance with parts 210 and 211. This guidance is not intended to place new expectations on manufacturers, nor to replace the CGMP requirements. Readers are advised to always refer to parts 210 and 211 to ensure full compliance with the regulations.
ComplianceOnline Trainings
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Featured Trainings:
Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities
This DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.
This DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.
OTC Drug Regulations
This webinar will provide attendees with the knowledge and skills needed to develop and produce an OTC drug product for marketing and sale in the U.S.
This webinar will provide attendees with the knowledge and skills needed to develop and produce an OTC drug product for marketing and sale in the U.S.
FDA Regulation and Legislation of Cosmetics
The webinar training will cover FDA regulations for marketing cosmetics and help attendees learn about new proposed legislation which will place new requirements on cosmetic product marketing in the U.S.
The webinar training will cover FDA regulations for marketing cosmetics and help attendees learn about new proposed legislation which will place new requirements on cosmetic product marketing in the U.S.
Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.
This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.
Preparing Compliant eCTD Submissions: Are You Prepared for Upcoming FDA Mandate on e-Submissions?
This webinar will review the CTD format requirements including documentation and technical requirements for an eCTD submissions. It will help attendees prepare for implementing the FDA upcoming mandates on e-submissions.
This webinar will review the CTD format requirements including documentation and technical requirements for an eCTD submissions. It will help attendees prepare for implementing the FDA upcoming mandates on e-submissions.
