Change Control Form (CCF)

 A Change Control Form (CCF) is a document used in various industries, including pharmaceuticals, to track changes to a process, product or system. It is a formal request for a change to be made, and serves as a way to document and manage the change process.

In the pharmaceutical industry, CCFs are particularly important for ensuring that changes to a product or process are made in a controlled and documented manner. This is because any changes to a pharmaceutical product or process can have significant impact on the safety, efficacy and quality of the product.

A typical CCF will include information such as the reason for the change, the scope of the change, the potential impact of the change, the proposed implementation date, and a description of the testing and validation required to ensure the change is successful. The CCF is typically reviewed and approved by a change control board or similar group before the change is implemented.


Comments

Post a Comment

Popular posts from this blog

What is Quality Control

  The term quality control refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical product. It involves in chemical, physical and some time microbiological testing of a pharmaceutical product. Quality control involves testing of pharmaceutical products against the specifications. The other responsibilities of Quality Control are sampling of Raw & packing material, Testing of raw material, packing material, In process, Finished product& Stability batches, Sampling & testing of water, Calibration of Instruments, Preparation of Specification of Raw, Packing, In process & Finished products, Preparation of Standard Test procedure of Raw, Packing, In process & Finished products and reporting of result after analysis & preparation of COA.
Read more

Laboratory Controlled Records

  Laboratory Controlled Records (LCR) refer to a type of documentation that is used in laboratory settings to maintain accurate and complete records of experiments and research activities. LCRs are critical to maintaining the quality and integrity of laboratory data, ensuring that results are reliable, reproducible, and traceable. LCRs typically include detailed information on the experimental design, procedures, and results. This may include the date and time of the experiment, the names and roles of the individuals involved, descriptions of materials and equipment used, measurements and observations taken, and any calculations or analyses performed. LCRs must be maintained in a manner that ensures their accuracy and completeness, and they must be readily accessible to authorized personnel. They may be in the form of handwritten notes, electronic records, or a combination of both. LCRs are subject to strict regulatory requirements and may be subject to review by regulatory...
Read more

Process Control test procedures

  Process control test procedures are used to ensure that manufacturing processes are operating within established limits and are capable of consistently producing high-quality products. These procedures are designed to monitor critical process parameters and to detect any deviations from established norms. The following are some common steps in process control test procedures: 1.     Identify Critical Control Points: The first step is to identify the critical control points in the manufacturing process. These are the points where the process is most likely to deviate from established norms and where corrective action may be necessary. 2.     Establish Acceptance Criteria: The next step is to establish acceptance criteria for the critical control points. This involves setting limits for process parameters such as temperature, pressure, flow rate, and pH, as well as defining acceptable ranges for product attributes such as size, weight, and ...
Read more