The document 'guidance on the occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers of active substances used as starting materials', published as part of the Community procedures, states that it is expected that manufacturing-authorisation holders will gain assurance that the active substances they use are manufactured in accordance with GMP through audit of the active-substance suppliers. Small manufacturers may not have the necessary expertise or resource to conduct their own audits.
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Section 5.25 of the GMP guideline requires starting materials to be purchased from approved suppliers and about whom the manufacturer has a particular and thorough knowledge.
An audit conducted by the manufacturing-authorisation holder itself should be integral to the manufacturer's quality-assurance system and subject to the basic GMP requirements, i.e. conducted by properly qualified and trained staff, in accordance with approved procedures. It should be properly documented. These aspects can be inspected as necessary by the competent authorities.
If a third party is involved, the arrangements should be subject to chapter 7 of the GMP guideline. There should be evidence that the contract-giver has evaluated the contract-acceptor with respect to the aspects described above.
All parties involved should be aware that audit reports and other documentation relating to the audit will be made available for inspection by the competent authorities if requested. This should normally provide sufficient assurance that the results of an audit carried by the third party are credible, thus waiving the need for an audit conducted by the manufacturing-authorisation holder itself. However, it must also be satisfactorily demonstrated that there are no conflicts of interests. Conflicts of interests could arise for example from:
This topic should also be addressed in the technical contractual arrangements. Any measures taken by the contract-giver should be documented, e.g. signed undertakings by the auditors.
Similarly, the principles outlined above could be used to allow sharing of audit reports between different manufacturing-authorisation holders using the same active substance supplier, provided that the scope of the audits can be shown to be applicable to the active substances of mutual interest.
Active pharmaceutical ingredients (APIs) are the active components in a pharmaceutical drug that produce the required effect on the body to treat a condition. APIs are produced by processing chemical compounds. In a biologic drug, the active ingredient is known as a bulk process intermediate (BPI).
Despite high manufacturing expenses, strict regulatory policies, and policies in controlling drug prices in many countries, attractive opportunities have emerged in the API market due to growing cases of chronic diseases, including diabetes, asthma and cancer.
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The information provided in the download document is drafted for pharmaceutical executives, research and development (R&D) executives, quality control and quality assurance executives, as well as API manufacturers, distributors, suppliers, sales managers, process engineers, technicians, research associates and production chemists, and any other individuals involved in the operations of the API and active pharmaceutical intermediates industry.
The download contains detailed information on API manufacturers to aid in purchasing decisions, including product ranges and contact details.
Related Buyer’s Guides which cover an extensive range of pharmaceutical technologies, equipment, and manufacturers, can also be found here.
APIs are broadly categorised into two types – synthetic and natural. Synthetic APIs are further classified into innovative and generic synthetic APIs, based on the type of synthesis used.
Synthetic chemical APIs, also known as small molecules, constitute a large part of the pharmaceutical market, with many small molecule drugs commercially available in the market.
Natural APIs are used in making biologics, which are increasingly becoming the top-selling drugs in the market. Despite the growing demand, biologics are currently significantly fewer in number compared to small molecule drugs.
Based on the solubility, APIs are categorised into insoluble and soluble drugs.
Pharmaceutical Technology has listed the leading suppliers of active pharmaceutical ingredients and intermediates based on its intel, insights and decades-long experience in the sector. The list includes companies that can develop and supply high-quality pharmaceutical materials, including, but not limited to:
The list also includes suppliers of mixing and drying technologies, polymer coatings for drug delivery, extraction technologies for high-purity APIs, and dispersion and wet milling technology. Providers of automatic capsule filling machines, dry powder and liquid-based material handling systems, analytic services for biological assays, pharma tablet manufacturing machines, and custom synthesis services are detailed in the document as well.
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