DST teacher recently in the audit process, found that some customers of the sampling work by the QA to be responsible for, some pharmaceutical companies by the QC sampling, so who is responsible for the sampling, who is responsible for the authorization is appropriate? Today we will come to discuss the issue of sampling, let us start from the regulations, look at the relevant provisions.

NMPA 2010 version of GMP Article 12 of the basic requirements for quality control:

(III), authorized personnel shall take samples of raw and auxiliary materials, packaging materials, intermediate products, products to be packaged and finished products in accordance with the prescribed methods.

NMPA 2010 GMP Article 222 Sampling shall at least meet the following requirements:

Personnel of the (I) Quality Management Department have the right to enter the production area and storage area for sampling and investigation;

The (II) shall be sampled in accordance with approved operating procedures, which shall specify in detail:

1. Authorized samplers;......

FDA 21CFR Part211

Sec. 211.42 Design and construction features-Design and Build Requirements

(c)(1) Receipt, identification, storage, and withholding from use of components, drug product containers, closures, and labeling, pending the appropriate sampling, testing examination by the quality control unit before release for manufacturing or packaging.

Before release to production or packaging, the quality control department shall adopt appropriate sampling methods and testing to receive, identify, store and disable raw and auxiliary materials, drug containers, seals and labels.

EU GMP:

Quality Control Quality Control

1.9 Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organization, documentation and released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory. The basic requirements of Quality Control are that:质量控制是GMP的一部分，涉及取样、质量标准、检验、同样也涉及组织机构、文件和放行规程，以保证切实执行了必要的相关检验，并且确保物料或产品被判定符合要求之前不被放行使用或销售。质量控制的基本要求是：

(ⅰ) Adequate facilities, trained personnel and approved procedures are available for sampling and testing starting materials, packaging materials, intermediate, bulk, and finished products, and where appropriate for monitoring environmental conditions for monitoring for GMP purposes;

Adequate facilities, trained personnel and approved procedures for sampling and inspection of starting materials, packaging materials, intermediates, semi-finished products and finished products, as well as environmental monitoring required by GMP;

(ⅱ) Samples of starting materials, packaging materials,intermediate products, bulk products and finished products are taken by approved personnel and methods.

Sampling of starting materials, packaging materials, intermediate products, semi-finished products and finished products by approved personnel according to approved methods.

6.4 Quality Control personnel should have access to production areas for sampling and investigation as appropriate.

Quality control personnel should have access to the production area for sampling and investigation.

PIC/S GMP

2.8 The head of Quality Control generally has the following responsibilities:

The Quality Control Responsible generally has the following responsibilities:

(ⅲ) To ensure that all necessary testing is carried out and the associated records evaluated. Approve quality standards, sampling methods, inspection methods and other quality control procedures.

6.2 The Quality Control Department as a whole will also have other duties,such as to establish,validate and implement all quality control procedures,oversee the control of the reference and/or retention samples of materials and products when applicable,ensure the correct labeling of containers of materials and products,ensure the monitoring of the stability of the products,participate in the investigation of complaints related to the quality of the product, etc. All these operations should be carried out in accordance with written procedures and, where necessary, recorded.

The entire Quality Control Department will also have other responsibilities, such as establishing, verifying and implementing all quality control procedures, supervising the control of reference and/or retention of materials and products, ensuring correct labeling of materials and product containers, ensuring product stability inspections, and participating in product quality related complaints investigations.

6.4 Quality Control personnel should have access to production areas for sampling and investigation as appropriate.

Quality control personnel shall have access to the production area for sampling and investigation.

WHO GMP

17.3 Each manufacturer should have a QC function. The QC function should be independent of other departments and under the authority of a person with appropriate qualification and experience. Adequate resources must be available to ensure that all the QC arrangements are effectively and reliably carried out. The basic requirements for QC are as follows:

Each manufacturer should have a quality control department. The quality control department should be independent of other departments and managed by personnel with appropriate qualifications and experience. Adequate resources must be provided to ensure the effective and reliable implementation of all quality control tasks. The basic requirements for the quality control department are as follows:

(a)Adequate facilities, trained personnel and approved procedures must be available for sampling, inspecting, and testing materials, packaging materials, and intermediate, bulk, and finished products, and where appropriate for monitoring environmental conditions for GMP purposes;

Adequate facilities, trained personnel and approved procedures should be available to sample, review and test raw materials, packaging materials, intermediates, products to be packaged and finished products, and monitor environmental conditions as appropriate to meet GMP requirements;

(b)Samples of starting materials, packaging materials, intermediate products, bulk products and finished products must be Quality Control departments approved personnel.

The sampling of raw materials, packaging materials, intermediates, products to be packaged and finished products must be completed by personnel approved by the quality control department according to the specified sampling method.

To sum up, in addition to China's 2010 version of GMP regulations, which are sampled by the quality management department (QA or QC), the regulations of other major regulatory agencies are more likely to be done by the quality control department, including sampling for environmental monitoring.

From the perspective of QA, QA personnel are responsible for the supervision and maintenance of the whole quality management system. QA sampling can better ensure that the sampling process conforms to established procedures and specifications, and that sampling is representative and fair. QA has the advantage of overall planning and coordination of sampling, and can grasp the timing, frequency and method of sampling from the macro level to ensure the accuracy of subsequent quality assessment. They pay more attention to the compliance of the process and the guarantee of the quality system.

However, QC personnel also have a unique expertise in sampling. QC mainly focuses on the specific detection and analysis of samples, and they have a deep understanding and mastery of sampling techniques and requirements. QC sampling can accurately obtain the required samples according to the detection purpose and method, and ensure the reliability of the detection results. QC excels in the detailed operation of sampling and in the targeting of specific test items.

In fact, whether it is QA sampling or QC sampling, the goal is to meet the strict requirements of GMP. Ideally, the two should work closely together to form a synergy. QA ensures the standardization and comprehensiveness of sampling, while QC ensures the professionalism and accuracy of sampling.

In a perfect quality management system of pharmaceutical enterprises, the responsibilities and authorities of QA and QC in sampling work should be clearly defined, and a clear workflow and communication mechanism should be established. Only in this way can the reliability and stability of product quality be improved to the greatest extent while ensuring that the sampling meets the GMP requirements.