ISO Clean Air Standards-ISO 14644-1
ISO Clean Room Classification:-
Category: Definition/Abbreviation
Pharma Definition/Abbreviation, Pharma Beginners
Drug-Product-Impurity-Thresholds As per ICH Q3
Reporting/Identification/Qualification of Impurities.
Drug-Substance-Impurity-Thresholds As per ICH Q3
Types of Impurities- Organic Impurity (Degradation), In-organic impurity, Residual solvents (Class-I,II,III), elemental impurities, byproduct, heavy metals, reagents,ligands, salt, catalyst, toxic, process, leaching, Hydrolysis, Oxidation, reduction, stability, heat, light, contamination.
Elemental Impurities- Lead, Mercury,cadmium, Nickel,cobalt, arsenic. (USP-232,233)
Tablet Dissolution Stages-S1,S2 & S3 Criteria 
Categories
ALCOA ++
Data Integrity: ALCOA ++
Regulatory Definitions of Data Integrity
USFDA: “Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded original, and accurate (ALCOA)”.
MHRA: “The extent to which all data are complete, consistent, and accurate throughout the data lifecycle.”
WHO: “Data integrity is the degree to which a collection of data is complete, consistent and accurate throughout the data lifecycle. The collected data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate”.
PICS: “Data Integrity is defined as the extent to which all data are complete, consistent, and accurate, throughout the data lifecycle”.
| Attributable | The Identity of the person completing a record (Who, When, Why). |
| Legible | The data is readable, Understandable, Traceable, Permanent allowing for a clear picture of the activities that occurred. |
| Contemporaneous | The data is recorded at the time it is generated or observed (No Back dating). |
| Original | Original Records must preserve data accuracy, completeness, content and meaning. Data as the file or format in which it was initially generated. |
| Accurate | The data record must be accurate whether paper or electronic, it must be exact, true and free from error (this might require a second verification if necessary). |
| Consistent | Consistent application of date and time stamps in the expected sequence. |
| Complete | All Information needs to be maintained. Batch pass-fail, Reanalyses carried out. (OOS, OOT). |
| Enduring | Medium used to record data should be permanent and not temporary memory RAM. |
| Available | Available/Accessible for review / audit for the life time of the record. |
Title:-Country & Regulatory Agencies:
| India | DCGI | Drug Controller General of India |
| India | CDSCO | Central Drugs Standard Control Organization |
| World | WHO | World Health Organization |
| USA | USFDA | U S Food and Drug Administration |
| UK | MHRA | Medicines and Healthcare products Regulatory Agency |
| EU | EMA | European Medicines Agency |
| EU | EDQM | European Directorate for Quality of Medicines |
| South Africa | MCC | The Medicines Control Council |
| Australia | TGA | Therapeutic Goods Administration |
| Japan | PMDA | Pharmaceutical Medical Devices Agency |
| Canada | TPD | Therapeutic Products Directorate |
| Singapore | HSA | Health Sciences Authority |
| Russia | Ministry of Health | |
| Brazil | ANVISA | Agência Nacional de Vigilância Sanitária |
| Switzerland | SWISSMEDIC | Swiss Agency for Therapeutic Products |
| Arab States | GCC | Gulf Cooperation Council |
Categories
Basic Concept of Pharma-2
Commissioning: Ensures that utilities, manufacturing facilities and equipment is designed properly and functions as intended as defined in the URS.
Deviation: Deviation is any change from written procedure like Protocols, SOP, STP, BMR. Etc. Any deviation from established procedures should be documented and explained. Critical deviations should be investigated and the investigation and its conclusion should be documented.
Incident: It’s an unwritten event that is against GMP. Incident can be defined as unplanned or uncontrolled event in the form of non-compliance from the designed systems or procedures
at any stage of manufacturing, packing, testing, holding and storage of drug product due to system.
Out of Specifications (OOS): Results generated during testing that do not comply with relevant standard or specification.
Out of Trends (OOT): Any test result obtained for a particular batch that is markedly different from the results of batches in a series.
Change Control: A Process which ensures that changes to procedures, materials, methods, equipment, and software are properly documented, approved, validated and traceable.
Corrective Action and Preventive Action (CAPA): CAPA consists of improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations.
Corrective Action: Action required to correct and prevent a re-occurrence for something that happened yesterday
Preventive Action: Action required to prevent an occurrence of something that may happen tomorrow
Root Cause Analysis: Root cause analysis is a problem solving technique for identifying the basic or cause factor (s) that underlie the occurrence or possible occurrences of an adverse event in a process similar to diagnosis of disease – with the goal always in mind of preventing reoccurrence.
Risk Assessment: A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.
User Requirements Specifications (URS): URS describes what users require from the system. URS are written early in the validation process, typically before the system is created
URS will be written by the system owner and End users, with input from Quality Assurance
Validation Plan: Validation Plan define the scope and goals of a validation project. These are specific to a single validation project. VP include deliverables to be generated during the validation process and Validation Team and the time line for completing the project.
Design Qualification (DQ): Documented verification that the proposed design of facilities, systems, and equipment is suitable for the intended purpose.
Functional Specifications (FS): The functional specifications document, if created, define functions and technological solutions that are specified for the computerized system based upon technical requirements needed to satisfy user requirements.
Functional Risk Assessment (FRA): A functional risk assessment is performed following approval of the functional specification to identify potential risks. Mitigation activities are then planned to manage the identified risks and allow focusing on critical areas, e.g.by modifying functionality, detailed testing, procedural controls or training.
Installation Qualification (IQ): Establishing a high degree of confidence that the equipment as installed is consistent with manufacture’s requirements and specifications.
Operating Qualification (OQ): Establishing a high degree of confidence that the equipment as installed is able to consistently operate within established limits and tolerances.
Performance Qualification (PQ): Establishing a high degree of confidence, with appropriate testing that the equipment, under normal operating conditions, will consistently produce a quality product.
Testing of Packing Materials
January 8, 2026
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Title: Testing of Packing Materials Objective: To provide general guideline, procedure, instructions for the Testing of Packing Materials used in packaging of Pharmaceuticals Products.
Microbial Limit Test For Material And Product
January 8, 2026
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Title: Microbial Limit Test For Material And Product Objective: Determination of Microbiological limit test for materials and products as per IP/BP/USP. 2. Principle:
Determination of Unsaponifiable Matter
January 8, 2026
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Title: Determination of Unsaponifiable Matter 1. Objective: Determination of Unsaponifiable Matter 2. Principle: The unsaponifiable matter consists of substances present in oils and fats
Determination of Nitrogen
January 8, 2026
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Title: Determination of Nitrogen 1. Objective: Determination of nitrogen in organic samples. 2. Principle: The decomposition of nitrogen in organic samples by boiling with
Determination of Friability of uncoated Tablets
January 8, 2026
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Title: Determination of Friability of uncoated Tablets 1. Objective: Determination of Friability of uncoated Tablets 2. Principle: This test is applicable to compressed tablets
Determination of uniformity content (As Per IP)
January 8, 2026
No Comments
Title: Determination of uniformity content 1. Objective: Determination of uniformity content of single- dose preparation as per IP. 2. Principle: The test for
Form 482: FDA may conduct an inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response to a reported problem. The investigator will present credentials and “Notice of Inspection” upon arriving at your plant.
Form 483: An FDA form 483 is issued to firm management at the conclusion of an inspection when an investigator has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related acts.
CDSCO: The Central Drugs Standard Control Organisation is India’s national regulatory body for pharmaceuticals and medical devices. The Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices and is positioning within the Ministry of Health and Family Welfare.
- CDSCO exercises regulatory control over the quality of drugs, cosmetics and notified medical devices in the country.
- It is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.
EMA: The European Medicines Agency is an agency of the European Union in charge of the evaluation and supervision of medicinal products.
- EMA is responsible for scientific evaluation, supervision and safety monitoring of medicines in EU.
- Protects public health and animal health in 28 EU member states, as well as the countries of the European Economic Area.
PIC/S: Pharmaceutical Inspection Convention/ Pharmaceutical Inspection Co-operation Scheme
The main aim of PIC/S is to improve the Co-operation in the field of GMP between regulatory authorities and pharmaceutical industry.
PIC was founded in 1970 by European Free Trade Association (EFTA), Because of incompatibility between convention and European law, it was not possible for new countries to be admitted as members of PIC. As a consequence, the Pharmaceutical Inspection Co- operation Scheme was formed on 2 November 1995.
ICH: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
ICH Products: Quality, Safety, Efficacy, Multidisciplinary
WHO: The World Health Organization is a specialized agency of the United Nations responsible for international public health. The WHO Constitution, which establishes the agency’s governing structure and principles, states its main objective as “the attainment by all peoples of the highest possible level of health”
Regulatory Affairs: Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their marketing.
Validation: Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and Quality Attributes. (Validation is Process Oriented)
Verification: Verification is the act or process of establishing the truth or reality of something.
Qualification: Is an act or process to assure something complies with some condition, standard or specific requirements.