GMP

API Audit

An API (Active Pharmaceutical Ingredient) is the substance responsible for the effect that a medicine produces in the body to treat a condition. In an API GMP audit, the API specifications, test methods, results of stability studies, impurity profile, processes, and cleaning validation will be reviewed under GMP standards.

Excipients Audit

Pharmaceutical excipients are inert substances that are combined with APIs to form medicines and facilitate their dosage. They are essential for medications to be effective, as they influence how the medication enters and interacts with the body. 

A GMP audit for excipients includes the review of Quality Management System principles, such as responsibility management, change control, documentation requirements, resource management, or excipient manufacturing.

Finished Dosages

A finished dosage refers to the combination of at least one active pharmaceutical ingredient and other ingredients that constitute the form in which it will be administered to the patient (e.g., tablet, capsule, or solution). 

The finished dosage audit shall ensure that these forms are manufactured in accordance with the GMP standards through verification of materials, components and labelling, handling and storage, and inspection of the finished product by sampling and testing required for release. Regarding packaging operations, checks shall be carried out to ensure the area and equipment are free from residues and contaminants.

Packaging

Packaging materials for medicinal products protect the product from external factors such as light, air, moisture, and contamination and ensure product integrity throughout its lifecycle. Packaging materials can be classified into primary packaging materials when they are in direct contact with the product and secondary packaging materials when not in direct contact with the product, but still provide additional protection during transport and storage. 

Due to their direct impact on the medicinal product, the manufacture of primary packaging materials for medicinal products should follow the ISO15378 standard, which provides GMP principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products. 

An audit for the manufacture of a primary packaging material should cover several topics, including the qualification of suppliers, the control of raw materials and components, the validation and control of processes, the qualification and maintenance of equipment, and the monitoring of product quality.

Medical Device

GMP for medical devices ensures that the product is manufactured and controlled according to appropriate quality standards that minimize the associated risks. 

An audit for GMP medical devices shall review design and development protocols, SOPs, and other documents to identify and verify production controls and purchasing controls to check whether procedures and processes comply with ISO 13485 and FDA’s 21 CFR 820.30. 

The audit will also review documentation, records, and customer-related processes such as intended use, customer communications, and product orders.

Subcontracted Laboratory

Subcontracted Laboratory Contract laboratories provide analytical services to manufacturers. By applying GMP, we can ensure that the manufacturing process is safe, including in-process controls and testing. 

An audit of the subcontracted laboratory includes, among others: 

– A review of protocols and their compliance
– Inspection of ongoing studies – Review of records
– Final reports – Data transfer
– Inspection of facilities and equipment
– Review of organizational structure
– Evaluation of staff training.

Starting Materials

GMP for starting materials ensures that products are consistently produced and controlled according to quality standards. It’s designed to minimize the risks involved in pharmaceutical production that cannot be eliminated through testing the final product.

Starting Materials are raw materials or intermediates used in the production of an API and incorporated as a significant structural fragment into the structure of the final API. 

GMP requirements must be met as soon as a starting material is first used in the active ingredient manufacturing process. 

An audit for starting materials should include (but is not limited to) verifying that the process and its associated control strategy will consistently provide the active substance of satisfactory quality. It should also include reviewing and verifying requirements (and expectations of the competent authority) to describe the manufacturing process of a starting material so that quality assurance can be conclusively verified throughout the whole process.